natgillin/translations-raw huggingface dataset:
Alogliptin was not teratogenic in rats or rabbits with a systemic exposure at the NOAELs far above the human exposure at the recommended dose.
Alogliptin ni bil teratogen pri podganah in kuncih pri sistemski izpostavljenosti s stopnjami NOAEL, ki so bile veliko večje od izpostavljenosti človeka pri priporočenem odmerku.
To be eligible, patients had to have had one or more of the following: myocardial infarction, stroke, percutaneous cardiac intervention or coronary artery bypass graft, acute coronary syndrome, coronary artery disease, or peripheral arterial obstructive disease.
Da bi bolniki ustrezali merilom za vključitev v študijo, so morali v anamnezi imeti enega ali več naslednjih dejavnikov ali stanj: miokardni infarkt, možgansko kap, perkutani poseg na srcu ali obvodno operacijo koronarnih arterij, akutni koronarni sindrom, bolezen koronarnih arterij ali obstruktivno bolezen perifernih arterij.
Intrinsic clearance is, therefore, reduced coupled with a higher unbound fraction of pioglitazone (see section 4.2).
Intrinzični očistek je torej manjši ob sočasnem večjem deležu nevezanega pioglitazona (glejte poglavje 4.2).
Patients should be observed for signs and symptoms of heart failure, weight gain or oedema; particularly those with reduced cardiac reserve.
Bolnike je treba nadzirati glede pojava znakov in simptomov srčnega popuščanja, povečanja telesne mase ali edemov, še posebej bolnike z zmanjšano srčno rezervo.
Post marketing cases of peripheral oedema and cardiac failure have also been reported in patients with concomitant use of pioglitazone and nonsteroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors.
V obdobju trženja so o primerih perifernega edema in srčnega popuščanja poročali tudi pri bolnikih, ki so se sočasno zdravili s pioglitazonom in z nesteroidnimi protivnetnimi zdravili (NSAIDs - nonsteroidal anti-inflammatory drugs), vključno s selektivnimi zaviralci COX-2.
The fracture incidence calculated was 1.9 fractures per 100 patient years in women treated with pioglitazone and 1.1 fractures per 100 patient years in women treated with a comparator.
Izračunana pojavnost zlomov je bila 1,9 zloma na 100 bolnikov-let pri ženskah, zdravljenih s pioglitazonom, in 1,1 zloma na 100 bolnikov-let pri ženskah, zdravljenih s primerjalnim zdravilom.
The maximum recommended daily dose of 25 mg alogliptin and 45 mg pioglitazone should not be exceeded.
Največji priporočeni dnevni odmerek Največjih priporočenih dnevnih odmerkov 25 mg alogliptina in 45 mg pioglitazona se ne sme preseči.
Higher doses of alogliptin decreased offspring body weight and exerted some developmental effects considered secondary to the low body weight.
Večji odmerki alogliptina so zmanjšali telesno maso mladičev in izkazali določene vplive na razvoj, ki so bili ocenjeni kot posledica majhne telesne mase.
For patients with mild renal impairment (creatinine clearance (CrCl) > 50 to ≤ 80 mL/min), no dose adjustment of Incresync is necessary (see section 5.2).
Pri bolnikih z blago okvaro ledvic (kreatininski očistek (CrCl - creatinine clearance) > 50 do ≤ 80 ml/min) odmerka zdravila Incresync ni treba prilagajati (glejte poglavje 5.2).
- if you have or have had a disease of the pancreas.
• če imate ali ste kdaj imeli bolezen trebušne slinavke.
Incresync tablets contain lactose.
Tablete zdravila Incresync vsebujejo laktozo.
However, as the distribution of AUC values for alogliptin in these patients was within the same range as control subjects, no dose adjustment of alogliptin for patients with mild renal impairment is necessary (see section 4.2).
Ker pa je bila porazdelitev vrednosti AUC alogliptina pri teh bolnikih v enakem razponu kot pri kontrolnih osebah, pri bolnikih z blago okvaro ledvic odmerka alogliptina ni treba prilagajati (glejte poglavje 4.2).
Steady-state pharmacokinetics is similar in patients aged 65 years and over and young subjects (see section 4.2).
Farmakokinetika v stanju dinamičnega ravnovesja je pri bolnikih, starih 65 let ali starejših, podobna kot pri mlajših osebah (glejte poglavje 4.2).
Combination treatment with alogliptin and pioglitazone to pregnant rats slightly augmented pioglitazone-related foetal effects of growth retardation and visceral variations, but did not induce embryo-foetal mortality or teratogenicity.
Kombinirano zdravljenje z alogliptinom in pioglitazonom je pri brejih podganah povzročilo rahel porast s pioglitazonom povezanih učinkov za plod v obliki zaostanka rasti in visceralnih variacij, ni pa povzročilo umrljivosti zarodkov/plodov ali teratogenosti.
Alogliptin works to increase the levels of insulin in the body after a meal and decrease the amount of sugar in the body.
Alogliptin deluje tako, da po obroku v telesu zviša koncentracijo insulina in zmanjša količino sladkorja.
Cases of bladder cancer were reported more frequently in a meta-analysis of controlled clinical studies with pioglitazone (19 cases from 12,506 patients, 0.15%) than in control groups (7 cases from 10,212 patients, 0.07%) HR=2.64 (95% CI 1.11-6.31, P=0.029).
V meta-analizi nadzorovanih kliničnih študij so o raku sečnega mehurja poročali pogosteje pri bolnikih, ki so prejemali pioglitazon (19 primerov od 12.506 bolnikov, 0,15 %) kot pri bolnikih v kontrolnih skupinah (7 primerov od 10.212 bolnikov, 0,07 %), HR=2,64 (95 % IZ 1,11-6,31, P=0,029).
The safety and efficacy of Incresync in children and adolescents < 18 years old have not been established.
Varnost in učinkovitost zdravila Incresync pri otrocih in mladostnikih, mlajših od 18 let, nista bili dokazani.
The maximum recommended daily dose is one 25 mg/45 mg tablet.
Največji priporočeni dnevni odmerek je ena tableta 25 mg/45 mg.
Studies in man suggest no induction of the main inducible cytochrome P450, 1A, 2C8/9 and 3A4.
Študije pri ljudeh ne kažejo indukcije glavnih inducibilnih izoencimov citokroma P450, 1A, 2C8/9 in 3A4.
Hepatic impairment Incresync must not be used in patients with hepatic impairment (see sections 4.3, 4.4 and 5.2).
Okvara jeter Pri bolnikih z okvaro jeter se zdravila Incresync ne sme uporabljati (glejte poglavja 4.3, 4.4 in 5.2).
Following oral administration of radiolabelled pioglitazone to man, recovered label was mainly in faeces (55%) and a lesser amount in urine (45%).
Pri človeku se je po peroralni uporabi z radioaktivnim izotopom označenega pioglitazona večina radioaktivnosti izločila z blatom (55 %), manjša količina pa z urinom (45 %).
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 or history of a serious hypersensitivity reaction, including anaphylactic reaction, anaphylactic shock, and angioedema, to any dipeptidyl-peptidase-4 (DPP-4) inhibitor (see sections 4.4 and 4.8)
• Preobčutljivost na zdravilni učinkovini ali katero koli pomožno snov, navedeno v poglavju 6.1, ali anamneza hude preobčutljivostne reakcije, vključno z anafilaktično reakcijo, anafilaktičnim šokom in angioedemom po uporabi katerega koli zaviralca dipeptidil-peptidaze (DDP-4 - dipeptidyl-peptidase) (glejte poglavji 4.4 in 4.8).
Incresync should be used with caution during concomitant administration of cytochrome P450 2C8 inhibitors (e.g. gemfibrozil) or inducers (e.g. rifampicin).
Zdravilo Incresync je treba uporabljati previdno pri sočasnem zdravljenju z zaviralci citokroma P450 2C8 (npr. gemfibrozil) ali njegovimi induktorji (npr. rifampicin).
Incresync combines two antihyperglycaemic medicinal products with complementary and distinct mechanisms of action to improve glycaemic control in patients with type 2 diabetes mellitus: alogliptin, a dipeptidyl-peptidase-4 (DPP-4) inhibitor, and pioglitazone, a member of the thiazolidinedione class.
Zdravilo Incresync je kombinacija dveh antihiperglikemičnih zdravil s komplementarnim in ločenim mehanizmom delovanja, namenjeno za izboljšanje urejenosti glikemije pri bolnikih s sladkorno boleznijo tipa 2: alogliptina, zaviralca dipeptidil-peptidaze-4 (DPP-4) in pioglitazona, ki spada v skupino tiazolidindionov.
Incresync is taken when your blood sugar cannot be adequately controlled by diet, exercise and other oral anti-diabetic medicines such as pioglitazone; or pioglitazone and metformin taken together.
Zdravilo Incresync uporabljamo, če krvnega sladkorja ni mogoče dovolj dobro nadzorovati z dieto, s telesno vadbo in z drugimi peroralnimi zdravili za zdravljenje sladkorne bolezni, kot so pioglitazon ali pioglitazon in metformin, ki se ju jemlje skupaj.
Interactions with pioglitazone
Medsebojno delovanje s pioglitazonom
No information is available on pioglitazone and alogliptin use in dialysed patients and, therefore, co-administered alogliptin plus pioglitazone should not be used in such patients (see sections 4.2 and 5.2).
Pri bolnikih, ki se zdravijo z dializo, podatki o uporabi pioglitazona in alogliptina niso na voljo, zato se alogliptina skupaj s pioglitazonom pri takih bolnikih ne sme uporabljati (glejte poglavji 4.2 in 5.2).
Pioglitazone dose adjustment within the recommended posology or changes in diabetic treatment should be considered (see section 4.5).
Morda bo treba prilagoditi odmerek pioglitazona v okviru priporočenega odmerjanja ali spremeniti zdravljenje sladkorne bolezni (glejte poglavje 4.5).
Hypersensitivity reactions, including Stevens-Johnson syndrome, anaphylactic reactions, and angioedema are serious and are attributed to the alogliptin component of Incresync (see section 4.4).
Preobčutljivostne reakcije, vključno s Stevens-Johnsonovim sindromom, anafilaktičnimi reakcijami in angioedemom, so resne in je mogoče pripisati vsebnosti alogliptina v zdravilu Incresync (glejte poglavje 4.4).
In clinical studies with pioglitazone, the incidence of elevations of ALT greater than three times the upper limit of normal was equal to placebo but less than that seen in metformin or sulphonylurea comparator groups.
V kliničnih študijah s pioglitazonom je bila pojavnost zvišanj vrednosti ALT na več kot trikratno zgornjo mejo normalnih vrednosti enaka kot pri placebu, a manjša kot v primerjalnih skupinah z metforminom ali s sulfonilsečnino.
- A severe allergic reaction: skin lesions or spots on your skin that can progress to a sore surrounded by pale or red rings, blistering and/or peeling of the skin possibly with symptoms such as itching, fever, overall ill feeling, achy joints, vision problems, burning, painful or itchy eyes and mouth sores (Stevens-Johnson syndrome and Erythema multiforme).
• Huda alergijska reakcija: pojav kožnih sprememb ali lis na koži, ki lahko napredujejo do razjed, obdanih z bledimi ali rdečimi obročki, spremljajo pa jih lahko simptomi, kot so srbenje, zvišana telesna temperatura, splošno slabo počutje, bolečine v sklepih, težave z vidom, pekoče, boleče ali srbeče oči in razjede v ustih (Stevens-Johnsonov sindrom in multiformni eritem).
Caution should be exercised in patients with a history of pancreatitis.
Pri bolnikih z anamnezo pankreatitisa je potrebna previdnost.
- if you have liver disease.
• če imate bolezen jeter.
Interaction studies have shown that pioglitazone has no relevant effect on either the pharmacokinetics or pharmacodynamics of digoxin, warfarin, phenprocoumon or metformin.
Študije medsebojnega delovanja so pokazale, da pioglitazon nima pomembnih učinkov na farmakokinetiko ali farmakodinamiko digoksina, varfarina, fenprokumona ali metformina.
The improved glycaemic control is associated with a reduction in both fasting and postprandial plasma insulin concentrations.
Boljša urejenost glikemije je povezana z zmanjšanjem koncentracije insulina v plazmi tako na tešče kot po obroku.
In an outcome study of patients with pre-existing major macrovascular disease, the incidence of serious heart failure was 1.6% higher with pioglitazone than with placebo when added to therapy that included insulin.
V študiji izidov pri bolnikih s predhodno obstoječo hudo makrovaskularno boleznijo je bila pojavnost hudega srčnega popuščanja pri dodatku pioglitazona k zdravljenju, ki je vključevalo insulin, za 1,6 % večja kot pri dodatku placebu.
Your doctor will check whether Incresync is working 3 to 6 months after you start taking it.
Zdravnik bo 3 do 6 mesecev po uvedbi zdravljenja preveril, če je zdravljenje z zdravilom Incresync učinkovito.
This was determined by clinically relevant and statistically significant reductions in glycosylated haemoglobin (HbA1c) and fasting plasma glucose compared to control from baseline to study endpoint.
To je bilo dokazano s klinično pomembnim in statistično značilnim zmanjšanjem vrednosti glikoziliranega hemoglobina (HbA1c) in vrednosti glukoze v plazmi na tešče v primerjavi s kontrolo od izhodišča do končne opazovane vrednosti v študiji.
In PROactive, a cardiovascular outcome study, 5,238 patients with type 2 diabetes mellitus and pre-existing major macrovascular disease were randomised to pioglitazone or placebo in addition to existing anti-diabetic and cardiovascular therapy, for up to 3.5 years.
V študiji kardiovaskularnih izidov PROactive je bilo 5.238 bolnikov s sladkorno boleznijo tipa 2 in predhodno obstoječo hudo makrovaskularno boleznijo randomiziranih na pioglitazon ali placebo, oboje kot dodatek k dotedanjemu antidiabetičnemu in kardiovaskularnemu zdravljenju, in sicer za obdobje do 3,5 let.
Risk related to pioglitazone
Tveganja, povezana s pioglitazonom
• as an adjunct to diet and exercise to improve glycaemic control in adult patients (particularly overweight patients) inadequately controlled on pioglitazone alone, and for whom metformin is inappropriate due to contraindications or intolerance.
• kot dodatek k dieti in telesni vadbi za izboljšanje urejenosti glikemije pri odraslih bolnikih (še posebej bolnikih s prekomerno telesno maso) z neustrezno urejeno sladkorno boleznijo pri zdravljenju samo s pioglitazonom in pri katerih uporaba metformina zaradi kontraindikacij ali intolerance ni primerna.
DPP-4 is the principal enzyme involved in the rapid degradation of the incretin hormones, glucagon-like peptide-1 (GLP-1) and GIP (glucosedependent insulinotropic polypeptide), which are released by the intestine and levels are increased in response to a meal.
DPP-4 je glavni encim, ki sodeluje pri hitri razgradnji inkretinov, glukagonu podobnega peptida-1 (GLP-1; “glucagon-like peptide-1”) in od glukoze odvisnega insulinotropnega polipeptida (GIP; “glucose-dependent insulinotropic polypeptide”), ki se izločata iz črevesa, njuna koncentracija pa se po obroku zviša.
Any macroscopic haematuria should be investigated before starting therapy.
Pred uvedbo zdravljenja je treba raziskati vsako makroskopsko hematurijo.
The incidence of hypoglycaemia was greater when alogliptin was used as triple therapy with pioglitazone and metformin (compared to active-control).
Pojavnost hipoglikemije je bila večja, če je bil alogliptin uporabljen v okviru trotirnega zdravljenja s pioglitazonom in z metforminom (v primerjavi s kontrolnim zdravilom).
Therefore, in order to maintain systemic exposures to alogliptin that are similar to those observed in patients with normal renal function, lower doses of alogliptin should be used in patients with moderate or severe renal impairment, or end-stage renal disease requiring dialysis (see above and section 4.2).
Zaradi ohranjanja sistemskih izpostavljenosti alogliptinu, podobnih tistim, ki so bile opažene pri bolnikih z normalnim delovanjem ledvic, je pri bolnikih z zmerno ali s hudo okvaro ledvic ali bolnikih s končno ledvično odpovedjo, ki se zdravijo z dializo, treba uporabljati manjše odmerke alogliptina (glejte zgoraj in poglavje 4.2).
- if you are taking an anti-diabetic medicine known as sulphonylurea (e.g. glipizide, tolbutamide, glibenclamide) or insulin.
• če jemljete zdravilo za zdravljenje sladkorne bolezni, znano kot sulfonilsečnina (npr. glipizid, tolbutamid, glibenklamid), ali uporabljate insulin.
Treatment with pioglitazone has been shown to reduce hepatic glucose output and to increase peripheral glucose disposal in the case of insulin resistance.
Dokazano je bilo, da zdravljenje s pioglitazonom zmanjša sproščanje glukoze iz jeter in poveča periferno porabo glukoze v primeru odpornosti proti insulinu.
There is no induction of the main inducible P450 isoenzymes 1A, 2C8/9 and 3A4 in man.
Pri človeku ni indukcije glavnih inducibilnih izoencimov P450 1A, 2C8/9 in 3A4.
Studies in animals with alogliptin plus pioglitazone as combination treatment have shown reproductive toxicity (slight augmentation of pioglitazone-related foetal growth retardation and foetal visceral variations, see section 5.3).
Študije kombiniranega zdravljenja z alogliptinom in pioglitazonom na živalih so pokazale vpliv na sposobnost razmnoževanja (rahlo povečanje zaostanka rasti plodov in visceralne variacije pri plodovih, povezanih z uporabo pioglitazona, glejte poglavje 5.3).
For patients intolerant to metformin or for whom metformin is contraindicated, inadequately controlled on pioglitazone alone, the recommended dose of Incresync is one tablet of 25 mg/30 mg or 25 mg/45 mg once daily, depending on the dose of pioglitazone already being taken.
Pri bolnikih, ki metformina ne prenašajo ali pa je njegova uporaba kontraindicirana, pri zdravljenju samo s pioglitazonom pa urejenost sladkorne bolezni ni zadostna, je priporočeni odmerek zdravila Incresync ena tableta 25 mg/30 mg ali 25 mg/45 mg enkrat na dan, odvisno od odmerka pioglitazona, ki ga bolnik že jemlje.
Since there is a potential for an increase in dose-related adverse reactions, a decrease in the dose of pioglitazone may be needed when gemfibrozil is concomitantly administered.
Ker obstaja možnost povečanja od odmerka odvisnih neželenih učinkov, bo pri sočasni uporabi gemfibrozila odmerek pioglitazona morda treba zmanjšati.
Minimal to mild simple transitional cell hyperplasia was seen in the urinary bladder of male rats at the lowest dose used (27 times the human exposure) without establishment of a clear NOEL (no observed effect level).
Pri samcih podgan so pri najnižjih uporabljenih odmerkih (27-kratna izpostavljenost človeka) poročali o minimalni do blagi enostavni hiperplaziji prehodnih celic sečnega mehurja, vendar pa jasna mejna vrednost brez opaženega učinka (NOEL; “no observed effect level”) ni bila ugotovljena.
In combination studies, pioglitazone added to metformin resulted in mean weight increase over one year of 1.5 kg and added to a sulphonylurea of 2.8 kg.
V študijah kombiniranega zdravljenja je pioglitazon, dodan k metforminu, povzročil povprečno povečanje telesne mase v enem letu za 1,5 kg, pioglitazon, dodan k sulfonilsečnini, pa za 2,8 kg.
In comparator groups, addition of sulphonylurea to metformin resulted in a mean weight gain of 1.3 kg and addition of metformin to a sulphonylurea a mean weight loss of 1.0 kg.
V primerjalnih skupinah je dodatek sulfonilsečnine k metforminu povzročil povprečno povečanje telesne mase za 1,3 kg, dodatek metformina k sulfonilsečnini pa povprečno zmanjšanje telesne mase za 1,0 kg.
The recommended dose is one tablet of 25 mg/30 mg or 25 mg/45 mg once daily, depending on the dose of pioglitazone already being taken.
Priporočeni odmerek je ena tableta 25 mg/30 mg ali 25 mg/45 mg enkrat na dan, odvisno od odmerka pioglitazona, ki ga bolnik že jemlje.
In patients with moderate or severe renal impairment, or end-stage renal disease on haemodialysis, an increase in systemic exposure to alogliptin of approximately 2- and 4-fold was observed, respectively.
Pri bolnikih z zmerno ali s hudo okvaro ledvic ali s končno ledvično odpovedjo na hemodializi so opazili približno 2-kratno oziroma 4-kratno povečanje sistemske izpostavljenosti alogliptinu.
In clinical studies with pioglitazone, there was evidence of dose-related weight gain, which may be due to fat accumulation and, in some cases, associated with fluid retention.
V kliničnih študijah pioglitazona so opazili od odmerka odvisno povečanje telesne mase, ki je lahko posledica kopičenja maščobe, v nekaterih primerih pa je lahko povezano z zastajanjem tekočine.
In healthy subjects, alogliptin had no effect on prothrombin time or International Normalised Ratio (INR) when administered concomitantly with warfarin.
Pri zdravih osebah alogliptin pri sočasni uporabi z varfarinom ni vplival na protrombinski čas ali internacionalno normalizirano razmerje (INR).
Microcrystalline cellulose Hydroxypropylcellulose Croscarmellose sodium Magnesium stearate Lactose monohydrate
Jedro tablete manitol mikrokristalna celuloza hidroksipropilceluloza premreženi natrijev karmelozat magnezijev stearat laktoza monohidrat
In the 3.5 year PROactive study, 44/870 (5.1%) of pioglitazone-treated female patients experienced fractures compared to 23/905 (2.5%) of female patients treated with comparator.
V 3,5 let trajajoči študiji PROactive so o zlomih poročali pri 44/870 žensk (5,1 %), ki so se zdravile s pioglitazonom, v primerjavi s 23/905 žensk (2,5 %), ki so se zdravile s primerjalnim zdravilom.
Minimal quantities of alogliptin are removed by haemodialysis (approximately 7% of the substance was removed during a 3-hour haemodialysis session).
Pri hemodializi se odstranijo le majhne količine alogliptina (med 3-urno hemodializo se ga je odstranilo le približno 7 %).
Two minor metabolites were detected following administration of an oral dose of [14C] alogliptin, N-demethylated alogliptin, M-I (< 1% of the parent compound), and N-acetylated alogliptin, M-II (< 6% of the parent compound).
Po uporabi peroralnega odmerka z radioaktivnim izotopom označenega [14C] alogliptina sta bila zaznana dva manj pomembna presnovka, in sicer N-demetiliran alogliptin, M-I (< 1 % izvorne spojine), in N-acetiliran alogliptin, M-II (< 6 % izvorne spojine).
Table 1: Adverse reactions System organ class Adverse reaction
Preglednica 1: Neželeni učinki Organski sistem Neželeni učinek
Thus, free (unbound) pioglitazone concentration is unchanged (see section 4.2).
Zato je koncentracija prostega (nevezanega) pioglitazona nespremenjena (glejte poglavje 4.2).
Visceral fat was significantly decreased while there was an increase in extra-abdominal fat mass.
Visceralno maščevje se je značilno zmanjšalo, masa zunajtrebušnega maščevja pa se je povečala.
Total exposure to alogliptin was approximately 10% lower and peak exposure was approximately 8% lower in patients with moderate hepatic impairment compared to control subjects.
Pri bolnikih z zmerno okvaro jeter je bila skupna izpostavljenost alogliptinu približno za 10 % manjša, največja izpostavljenost pa približno za 8 % manjša v primerjavi s kontrolnimi osebami.
A total of 3,504 patients with type 2 diabetes mellitus, including 1,908 patients treated with alogliptin and pioglitazone, participated in 4 phase 3 double-blind, placebo- or active-controlled clinical studies conducted to evaluate the effects of co-administered alogliptin and pioglitazone on glycaemic control and their safety.
Skupno 3.504 bolniki s sladkorno boleznijo tipa 2, vključno s 1.908 bolniki, zdravljenimi z alogliptinom in s pioglitazonom, so bili vključeni v 4 dvojno slepe, s placebom ali z zdravilno učinkovino nadzorovane klinične študije 3. faze, z namenom ovrednotenja učinkov sočasne uporabe alogliptina in pioglitazona na urejenost glikemije in njuno varnost.
Frequency of adverse reactions Alogliptin Pioglitazone Incresync
Pogostnost neželenih učinkov Alogliptin Pioglitazone
Symptoms of a serious allergic reaction may include; rash, raised red patches on your skin (hives), swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing.
Simptomi hude alergijske reakcije lahko vključujejo izpuščaj, izbokle rdeče izpuščaje na koži (koprivnica), otekanje obraza, ustnic, jezika in žrela, kar lahko povzroči težave pri dihanju ali požiranju.