FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not take Komboglyze - If you are allergic to saxagliptin, metformin or any of the other ingredients of this medicine (listed in section 6); - If you have had a serious allergic (hypersensitive) reaction to any other similar medications that you take to control your blood sugar.
Slovenian: Ne jemljite zdravila Komboglyze: če ste alergični na saksagliptin, metformin ali katero koli sestavino tega zdravila (navedeno v poglavju 6); če ste kdaj imeli resno alergijsko (preobčutljivostno) reakcijo na katera druga podobna zdravila, ki jih jemljete za uravnavanje vašega sladkorja v krvi.
English: Adverse reactions of hypoglycaemia were based on all reports of hypoglycaemia; a concurrent glucose measurement was not required.
Slovenian: Neželeni učinki hipoglikemije temeljijo na vseh poročilih o hipoglikemijah; sočasna meritev glukoze ni bila potrebna.
English: This has been shown at therapeutic doses in controlled, medium-term or long-term clinical studies: metformin reduces total cholesterol, LDL-C and triglyceride levels.
Slovenian: To je bilo v terapevtskih odmerkih dokazano v kontroliranih srednjeročnih in dolgoročnih kliničnih študijah: metformin zmanjša koncentracijo celotnega holesterola, holesterola LDL in trigliceridov.
English: Arthralgia has also been reported during postmarketing surveillance (see section 4.4).
Slovenian: O artralgiji so poročali tudi med nadzorom v obdobju trženja (glejte poglavje 4.4).
English: The intra-subject coefficients of variation for saxagliptin Cmax and AUC were less than 12%.
Slovenian: Intraindividualna koeficienta variacije za Cmax in AUC saksagliptina sta bila manj kot 12 %.
English: Mean absolute lymphocyte counts remained stable with daily dosing up to 102 weeks in duration.
Slovenian: Povprečno absolutno število limfocitov je ostalo stabilno med dnevno uporabo do 102. tedna.
English: Saxagliptin (N=8280)
Slovenian: Saksagliptin (N = 8280)
English: Clinical data described below suggest that the risk for clinically meaningful interactions with co-administered medicinal products is low.
Slovenian: Spodaj opisani klinični podatki kažejo, da je tveganje za klinično pomembna medsebojna delovanja med sočasno uporabo z drugimi zdravili majhno.
English: • inflamed stomach (gastritis) or gut, sometimes caused by an infection (gastro-enteritis)
Slovenian: • vnetje želodca (gastritis) ali črevesa, včasih zaradi okužbe (gastroenteritis)
English: As initial combination with metformin: gastritis (common), arthralgia
Slovenian: Kot uvodna kombinacija z metforminom: gastritis (pogosto), artralgija
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, da se metformin izloča z glomerulno filtracijo in tubularno sekrecijo.
English: A study conducted in seven normal healthy volunteers showed that cimetidine, administered as 400 mg twice daily, increased metformin systemic exposure (AUC) by 50% and Cmax by 81%.
Slovenian: Študija, opravljena pri sedmih normalnih zdravih prostovoljcih, je pokazala, da je cimetidin v odmerku 400 mg dvakrat na dan povečal sistemsko izpostavljenost (AUC) metforminu za 50 % in Cmax za 81 %.
English: p< 0.0001 compared to placebo.
Slovenian: p < 0,0001 v primerjavi s placebom.
English: Other medicines and Komboglyze
Slovenian: Druga zdravila in zdravilo Komboglyze
English: p-value < 0.0001. p-value=0.0166.
Slovenian: Vrednost p = 0,0166.
English: • infection of your sinuses, sometimes with a feeling of pain and fullness behind your cheeks and eyes (sinusitis)
Slovenian: • okužba obnosnih votlin, včasih z bolečinami in občutkom polnosti za lici in očmi (sinuzitis)
English: Kidney tests or checks
Slovenian: Preiskave ali preverjanje ledvic
English: Diabetic skin lesions are a common complication of diabetes.
Slovenian: Diabetične kožne spremembe so pogost zaplet sladkorne bolezni.
English: Thus, changes in blood protein levels in various disease states (e.g. renal or hepatic impairment) are not expected to alter the disposition of saxagliptin.
Slovenian: Zato ni pričakovati, da bi spremembe v koncentraciji beljakovin v krvi pri različnih bolezenskih stanjih (npr. okvari ledvic ali jeter) spremenile odstranjevanje saksagliptina.
English: Saxagliptin is a highly potent (Ki: 1.3 nM), selective, reversible, competitive, DPP4 inhibitor.
Slovenian: Saksagliptin je zelo močan (Ki: 1,3 nM), selektiven, reverzibilen in kompetitiven zaviralec DPP4.
English: Komboglyze must be discontinued at the time of surgery with general, spinal or epidural anaesthesia.
Slovenian: Uporabo zdravila Komboglyze je treba v času kirurškega posega pod splošno, spinalno ali epiduralno anestezijo prekiniti.
English: - Metformin is contraindicated in patients with a GFR < 30 mL/min and should be temporarily discontinued in the presence of conditions that alter renal function (see section 4.3).
Slovenian: - Metformin je kontraindiciran pri bolnikih z GFR< 30 ml/min in ga je treba začasno ukiniti, če se pojavijo stanja, ki spremenijo delovanje ledvic (glejte poglavje 4.3).
English: It is unknown whether saxagliptin is excreted in human milk, but metformin is excreted in human milk in small amounts.
Slovenian: Ni znano, ali se saksagliptin pri človeku izloča v materino mleko, metformin pa se pri človeku izloča v materino mleko v majhni količini.
English: Saxagliptin and metformin work together to control your blood sugar.
Slovenian: Saksagliptin in metformin delujeta skupaj in uravnavata vaš krvni sladkor.
English: The effects of smoking, diet, herbal products, and alcohol use on the pharmacokinetics of saxagliptin have not been specifically studied.
Slovenian: Vplivi kajenja, prehrane, pripravkov rastlinskega izvora in alkohola na farmakokinetiko saksagliptina, niso posebej raziskani.
English: Reductions in A1c were seen across subgroups including gender, age, race, and baseline BMI.
Slovenian: Zmanjšanje A1c so ugotovili tudi po podskupinah, vključno po spolu, starosti, rasi in izhodiščnem indeksu telesne mase (ITM).
English: The average renal clearance of saxagliptin (230 mL/min) was greater than the average estimated glomerular filtration rate (120 mL/min), suggesting some active renal excretion.
Slovenian: Povprečni ledvični očistek saksagliptina (230 ml/min) je bil večji kot povprečna ocenjena hitrost glomerularne filtracije (120 ml/min), kar kaže določeno mero aktivnega ledvičnega izločanja.
English: Animal studies with metformin do not indicate harmful effects with respect to pregnancy, embryonic or foetal development, parturition or postnatal development (see section 5.3).
Slovenian: Študije metformina na živalih ne kažejo škodljivih učinkov na nosečnost, embrionalni ali fetalni razvoj, porod ali poporodni razvoj (glejte poglavje 5.3).
English: If you have an allergic reaction, stop taking this medicine and call your doctor right away.
Slovenian: Če se pri vas pojavi alergijska reakcija, prenehajte jemati to zdravilo in takoj obvestite zdravnika.
English: Komboglyze may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly.
Slovenian: Zdravilo Komboglyze lahko povzroči zelo redek, a zelo resen neželeni učinek, imenovan laktacidoza, zlasti če ledvice ne delujejo pravilno.
English: Cationic substances that are eliminated by renal tubular secretion (e.g. cimetidine) may interact with metformin by competing for common renal tubular transport systems.
Slovenian: Kationske snovi, ki se izločajo z ledvično tubulno sekrecijo (npr. cimetidin), lahko medsebojno delujejo z metforminom s tekmovanjem za skupne ledvične tubulne transportne sisteme.
English: In case of suspected symptoms, the patient should stop taking Komboglyze and seek immediate medical attention.
Slovenian: Ob sumu na simptome mora bolnik prenehati z jemanjem zdravila Komboglyze in takoj poiskati zdravniško pomoč.
English: Other side effects of Komboglyze include:
Slovenian: Med drugimi neželenimi učinki zdravila Komboglyze so:
English: In particular, if you are following a diabetic weight control diet, keep on with this while you are taking this medicine.
Slovenian: Še zlasti če se držite diabetične diete za obvladovanje telesne mase, dieto nadaljujte tudi med jemanjem tega zdravila.
English: Metformin was uptitrated from 500 to 2000 mg per day as tolerated.
Slovenian: Odmerek metformina so povečevali od 500 do 2000 mg na dan, kot je bolnik prenesel.
English: Saxagliptin and its major metabolite can be removed by haemodialysis (23% of dose over 4 hours).
Slovenian: Saksagliptin in njegov glavni presnovek je mogoče odstraniti s hemodializo (23 % odmerka v 4 urah).
English: The mean metformin dose was approximately 1900 mg in each treatment group.
Slovenian: Povprečni odmerek metformina je bil v obeh terapevtskih skupinah približno 1900 mg.
English: Glucocorticoids (given by systemic and local routes), beta-2 agonists, and diuretics have intrinsic hyperglycaemic activity.
Slovenian: Glukokortikoidi (uporabljeni sistemsko ali lokalno), agonisti beta-2 in diuretiki imajo intrinzično hiperglikemično delovanje.
English: Special caution should be exercised in situations where renal function may become impaired, for example when initiating antihypertensive or diuretic therapy or when starting treatment with a NSAID.
Slovenian: Posebna pozornost je potrebna v okoliščinah, ko bi se lahko pojavila okvara delovanja ledvic, npr. na začetku zdravljenja z antihipertenzivi ali diuretiki ali ob uvedbi zdravljenja z NSAID.
English: The effect of saxagliptin on fertility in humans has not been studied.
Slovenian: Vpliv saksagliptina na plodnost pri človeku ni raziskan.
English: Evaluation should include serum electrolytes and ketones, blood glucose and, if indicated, blood pH, lactate, pyruvate, and metformin levels.
Slovenian: Ocena mora vključevati serumske elektrolite in ketone, glukozo v krvi in, če je indicirano, pH krvi in koncentracijo laktata, piruvata in metformina v krvi.
English: Events accumulated consistently over time, and the event rates for saxagliptin and placebo did not diverge notably over time.
Slovenian: Dogodki so se skozi čas kopičili stalno in deleži dogodkov se s saksagliptinom in placebom skozi čas niso občutno razhajali.
English: < 30 Metformin is contraindicated.
Slovenian: Metformin je kontraindiciran.
English: Event rate per 100 patient-years
Slovenian: Dogodki na 100 bolnik-let
English: • Lactic acidosis, Komboglyze may cause a very rare (may affect up to 1 user in 10,000), but very serious side effect called lactic acidosis (see section “Warnings and precautions”).
Slovenian: • Laktacidoza, zdravilo Komboglyze lahko povzroči zelo redek (pojavi se lahko pri največ 1 od 10.000 bolnikov), a zelo resen neželeni učinek, imenovan laktacidoza (glejte poglavje "Opozorila in previdnostni ukrepi").
English: The use of Komboglyze or saxagliptin has not been studied in pregnant women.
Slovenian: Uporaba zdravila Komboglyze ali saksagliptina pri nosečnicah ni raziskana.
English: So it is important to keep following the advice about diet and exercise from your doctor or nurse.
Slovenian: Zato je pomembno, da še naprej upoštevate navodila za dieto in telesno dejavnost, ki ste jih dobili od zdravnika ali medicinske sestre.
English: The time for saxagliptin to reach Cmax (Tmax) was increased by approximately 0.5 hours with food compared with the fasted state.
Slovenian: Čas, v katerem je saksagliptin dosegel Cmax (tmax), se je ob zaužitju s hrano podaljšal za približno 0,5 ure v primerjavi s stanjem na tešče.
English: A small decrease in absolute lymphocyte count was observed.
Slovenian: Opazili so majhno zmanjšanje absolutnega števila limfocitov.
English: Stop taking Komboglyze for a short time if you have a condition that may be associated with dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal.
Slovenian: Za kratek čas prenehajte jemati zdravilo Komboglyze, če imate stanje, ki je lahko povezano z dehidracijo (znatna izguba telesnih tekočin), kot je hudo bruhanje, driska, zvišana telesna temperatura, izpostavljenost vročini ali če pijete manj tekočine, kot običajno.
English: Food decreases the extent and slightly delays the absorption of metformin.
Slovenian: Hrana zmanjša absorpcijo metformina in jo rahlo upočasni.
English: Saxagliptin or metformin has a negligible influence on the ability to drive and use machines.
Slovenian: Saksagliptin ali metformin imata zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: Therefore, in keeping with routine care of the diabetic patient, monitoring for skin disorders, such as blistering, ulceration or rash, is recommended.
Slovenian: Zato je v skladu z rutinsko oskrbo sladkornega bolnika priporočljivo spremljanje glede kožnih sprememb, npr. mehurjev, razjed ali izpuščaja.
English: In rabbits, co-administration was poorly tolerated in many mothers, resulting in death, moribundity or abortion.
Slovenian: Pri kuncih so številne samice-matere sočasno uporabo slabo prenašale in je povzročila smrt, moribundnost ali splav.
English: Saxagliptin was not genotoxic in a conventional battery of genotoxicity studies in vitro and in vivo.
Slovenian: Saksagliptin ni bil genotoksičen v konvencionalni skupini študij genotoksičnosti in vitro in in vivo.
English: Avoid excessive alcohol intake while taking Komboglyze since this may increase the risk of lactic acidosis (see “Warnings and precautions”).
Slovenian: Med jemanjem zdravila Komboglyze ne uživajte čezmernih količin alkohola, saj lahko to poveča tveganje za laktacidozo (glejte poglavje "Opozorila in previdnostni ukrepi").
English: What you need to know before you take Komboglyze
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Komboglyze
English: You may need more frequent blood glucose and kidney function tests, or your doctor may adjust the dosage of Komboglyze.
Slovenian: Morda boste morali pogosteje opravljati preiskave glukoze v krvi in delovanja ledvic, zdravnik pa bo morda moral prilagoditi odmerek zdravila Komboglyze.
English: Caution is warranted if this medicinal product is used in patients who have known risk factors for hospitalisation for heart failure, such as a history of heart failure or moderate to severe renal impairment.
Slovenian: Previdnost je potrebna, če je to zdravilo uporabljeno pri bolnikih z znanimi dejavniki tveganja za hospitalizacijo zaradi srčnega popuščanja, npr. pri bolnikih z anamnezo srčnega popuščanja ali z zmerno do hudo okvaro ledvic.
English: • in patients inadequately controlled on their maximally tolerated dose of metformin alone
Slovenian: • ki je nezadostno urejena z največjim toleriranim odmerkom samega metformina;
English: Adjusted mean change from baseline adjusted for baseline value (ANCOVA).
Slovenian: Korigirana povprečna sprememba od izhodišča, korigirana za izhodiščno vrednosti (ANCOVA).
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: Ob običajnih odmerkih in odmernih shemah metformina je koncentracija v stanju dinamičnega ravnovesja v plazmi dosežena v 24 do 48 urah in je na splošno manjša od 1 µg/ml.
English: • flatulence
Slovenian: • flatulenca
English: Decrease in body weight in the treatment groups given saxagliptin in combination with metformin was similar to that in the groups given metformin alone.
Slovenian: Zmanjšanje telesne mase v terapevtskih skupinah, ki so dobivale saksagliptin v kombinaciji z metforminom, je bilo podobno kot v skupinah, ki so dobivale samo metformin.
English: In case of dehydration (severe diarrhoea or vomiting, fever, heat, reduced fluid intake), Komboglyze should be temporarily discontinued and contact with a health care professional is recommended.
Slovenian: V primeru dehidracije (huda driska ali bruhanje, zvišana telesna temperatura ali zmanjšan vnos tekočine) je treba jemanje zdravila Komboglyze začasno prekiniti; priporoča se posvet z zdravstvenim delavcem.
English: In addition, patients should be alerted to the risk of hypoglycaemia when Komboglyze is used in combination with other antidiabetic medicinal products known to cause hypoglycaemia (e.g. insulin, sulphonylureas).
Slovenian: Poleg tega je treba bolnike opozoriti na tveganje za hipoglikemijo, če je zdravilo Komboglyze uporabljeno v kombinaciji z drugimi antidiabetičnimi zdravili, za katere je znano, da povzročajo hipoglikemijo (npr. insulin, sulfonilsečnine).
English: The other ingredients (excipients) are:
Slovenian: Druge sestavine zdravila (pomožne snovi) so:
English: Renal function As metformin is excreted by the kidney, renal function should be assessed: - Before initiation of treatment and regularly thereafter (see sections 4.2, 4.8, 5.1 and 5.2).
Slovenian: Delovanje ledvic Ker se metformin izloča skozi ledvice, je treba oceniti delovanje ledvic: - Pred uvedbo zdravila in nato redno (glejte poglavja 4.2, 4.8, 5.1 in 5.2).
English: Includes saxagliptin in add-on to metformin and initial combination with metformin.
Slovenian: Vključuje saksagliptin kot dodatek metforminu in začetno kombinacijo z metforminom.
English: There have been no formal interaction studies for Komboglyze.
Slovenian: Z zdravilom Komboglyze niso izvedli formalnih študij medsebojnega delovanja.
English: Komboglyze with alcohol
Slovenian: Zdravilo Komboglyze skupaj z alkoholom
English: Table 4 The frequency of metformin adverse reactions identified from clinical trial and postmarketing data
Slovenian: Preglednica 4 Pogostnost neželenih učinkov metformina, ugotovljenih v kliničnih preskušanjih in iz obdobja trženja
English: If you forget to take Komboglyze
Slovenian: Če ste pozabili vzeti zdravilo Komboglyze
English: What Komboglyze is and what it is used for What you need to know before you take Komboglyze How to take Komboglyze
Slovenian: Kaj je zdravilo Komboglyze in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Komboglyze Kako jemati zdravilo Komboglyze Možni neželeni učinki
English: This is because metformin passes into human milk in small amounts.
Slovenian: Metformin namreč v majhni količini prehaja v materino mleko.
English: The rise in insulin from pancreatic beta-cells and the decrease in glucagon from pancreatic alpha-cells were associated with lower fasting glucose concentrations and reduced glucose excursion following an oral glucose load or a meal.
Slovenian: Povečanje insulina iz pankreatičnih celic beta in zmanjšanje glukagona iz pankreatičnih celic alfa sta bili povezani z manjšo koncentracijo glukoze na tešče in manjšim porastom glukoze po peroralni obremenitvi z glukozo ali po obroku.
English: Following administration of a dose of 850 mg, a 40% lower plasma peak concentration, a 25% decrease in AUC and a 35 min prolongation of time to peak plasma concentration was observed.
Slovenian: Po uporabi 850 mg odmerka so ugotovili 40 % manjšo največjo koncentracijo v plazmi, 25 % zmanjšanje AUC in 35-minutno podaljšanje časa do največje koncentracije v plazmi.
English: • redness of the skin (rash) or itching.
Slovenian: • pordelost kože (izpuščaj) ali srbenje.
English: • nausea, vomiting
Slovenian: • siljenje na bruhanje, bruhanje
English: The pharmacokinetics of saxagliptin and its major metabolite were similar in healthy subjects and in patients with type 2 diabetes.
Slovenian: Farmakokinetika saksagliptina in njegovega glavnega presnovka sta bili pri zdravih preiskovancih in bolnikih s sladkorno boleznijo tipa 2 podobni.
English: GENERATION was a 52-week glycaemic control study in 720 elderly patients, the mean age was 72.6 years; 433 subjects (60.1%) were < 75 years of age, and 287 subjects (39.9%) were ≥ 75 years of age.
Slovenian: Študija GENERATION je bila 52-tedenska študija urejenosti glikemije pri 720 starejših bolnikih, povprečno starih 72,6 let; 433 bolnikov (60,1 %) je bilo starih < 75 let, 281 bolnikov (39,9 %) pa je bilo starih ≥ 75 let.
English: The clinical significance of this decrease in lymphocyte count relative to placebo is not known.
Slovenian: Klinični pomen zmanjšanja števila limfocitov, v primerjavi s placebom, ni znan.
English: Another secondary endpoint, all-cause mortality, occurred at a rate of 5.1% in the saxagliptin group and 4.6% in the placebo group (see Table 7).
Slovenian: Drug sekundarni opazovani dogodek, umrljivost zaradi vseh vzrokov, se je v skupini s saksagliptinom pojavil v 5,1 % in v skupini s placebom v 4,6 % (glejte preglednico 7).
English: If you have or have had a disease of the pancreas;
Slovenian: če imate ali ste kdaj imeli bolezen trebušne slinavke (pankreasa).
English: For the major metabolite, renal clearance values were comparable to estimated glomerular filtration rate.
Slovenian: Za glavni presnovek so bile vrednosti ledvičnega očistka primerljive ocenjeni hitrosti glomerularne filtracije.
English: If this happens you must stop taking Komboglyze and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.
Slovenian: V tem primeru morate prenehati jemati zdravilo Komboglyze in se takoj obrniti na zdravnika ali najbližjo bolnišnico, saj lahko laktacidoza vodi v komo.
English: • muscle pain (myalgia)
Slovenian: • bolečina v mišici (mialgija)
English: Pack sizes of 14, 28, 56 and 60 film-coated tablets in non-perforated blisters.
Slovenian: Velikosti pakiranj s 14, 28, 56 in 60 filmsko obloženimi tabletami v neperforiranih pretisnih omotih.
English: Use with medicinal products known to cause hypoglycaemia Insulin and sulphonylureas are known to cause hypoglycaemia.
Slovenian: Uporaba z zdravili za katera je znano, da povzročajo hipoglikemijo Znano je, da insulin in sulfonilsečnine povzročajo hipoglikemijo.
English: Saxagliptin also resulted in a significantly lower proportion of patients with hypoglycaemia, 3% (19 events in 13 subjects) vs. 36.3% (750 events in 156 patients) for glipizide.
Slovenian: Saksagliptin je bil povezan tudi z značilno manjšim deležem hipoglikemij (3 %; 19 dogodkov pri 13 osebah) kot glipizid (36,3 %; 750 dogodkov pri 156 bolnikih).
English: Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose.
Slovenian: Metformin je bigvanid z antihiperglikemičnimi učinki, ki zmanjšuje bazalno in postprandialno glukozo v plazmi.
English: The SAVOR trial included 8240 patients treated with saxagliptin 5 mg or 2.5 mg once daily and 8173 patients on placebo.
Slovenian: Preskušanje SAVOR je zajelo 8240 bolnikov, zdravljenih z 2,5 mg ali 5 mg saksagliptina enkrat na dan, in 8173 bolnikov, ki so prejemali placebo.
English: Therapy may be restarted no earlier than 48 hours following surgery or resumption of oral nutrition provided that renal function has been re-evaluated and found to be stable.
Slovenian: Zdravljenje se sme ponovno uvesti najmanj 48 ur po kirurškem posegu ali začetku peroralnega prehranjevanja, če je bilo delovanje ledvic ponovno ovrednoteno in ocenjeno kot stabilno.
English: What Komboglyze looks like and contents of the pack
Slovenian: Izgled zdravila Komboglyze in vsebina pakiranja
English: You should call your doctor if you experience the following side effect: • severe joint pain.
Slovenian: Posvetujte se z zdravnikom, če se vam pojavijo naslednji neželeni učinki: • hude bolečine v sklepih.
English: Stop taking Komboglyze and contact a doctor or the nearest hospital immediately if you experience some of the symptoms of lactic acidosis, as this condition may lead to coma.
Slovenian: Takoj prenehajte jemati zdravilo Komboglyzein se obrnite na zdravnika ali najbližjo bolnišnico, če se pojavijo nekateri od simptomov laktacidoze, saj lahko to stanje vodi v komo.
English: Do not use this medicine if the package is damaged or shows signs of tampering.
Slovenian: Ne uporabljajte tega zdravila, če opazite, da je pakiranje poškodovano ali ima vidne znake, da ga je že kdo odpiral.