FrancophonIA/ELRC3.0 huggingface dataset:
English: This medicinal product contains less than 1 mmol sodium (23 mg) per maximum dose, i.e. essentially ‘sodium free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na največji odmerek, kar v bistvu pomeni »brez natrija«.
English: Dose increases will be decided by the child's doctor, using the table below as a guide, and will depend on both the effect of Sialanar and any side effects the patient is experiencing (this is why several dose levels appear in the table below).
Slovenian: Odločitev o zvečanju odmerka bo sprejel otrokov zdravnik s pomočjo spodnje preglednice ter bo odvisna od učinka zdravila Sialanar in morebitnih neželenih učinkov na bolnika (zato je v spodnji preglednici navedenih več ravni odmerka).
English: Check with the child's doctor during hot weather to see if the dose of Sialanar should be reduced.
Slovenian: Med vročim vremenom se posvetujte z otrokovim zdravnikom, da preverite, ali je treba odmerek zdravila Sialanar zmanjšati.
English: • abnormal blood brain barrier (the layer of cells surrounding the brain)
Slovenian: • nenormalno krvno-možgansko pregrado (plast celic, ki obkroža možgane).
English: • slow heart rate followed by rapid heart rate, palpitations and irregular heart beat
Slovenian: • počasen srčni utrip, ki mu sledi hiter srčni utrip, palpitacije in neenakomerno bitje srca
English: There are no data on the use of Sialanar in pregnant women.
Slovenian: Podatkov o uporabi zdravila Sialanar pri nosečnicah ni.
English: The Table 1 shows the dose in ml of solution to be given for each weight range at each dosing increase.
Slovenian: V preglednici 1 je prikazan odmerek v ml raztopine, ki se uporabi za vsak razpon telesne mase ob posameznem zvečanju odmerka.
English: Pre-hospital gastrointestinal decontamination with activated charcoal is not recommended because of the potential for somnolence and seizures and the resulting risk of pulmonary aspiration.
Slovenian: Dekontaminacija prebavil pred hospitalizacijo z aktivnim ogljem se odsvetuje zaradi možnosti somnolence in napadov ter posledičnega tveganja aspiracije pljuč.
English: These should be discussed with the child's doctor at all medical consultations, including those for dose increases and decreases, and at any other time should you be concerned.
Slovenian: O njih se posvetujte z otrokovim zdravnikom ob obisku zdravnika, tudi o neželenih učinkih pri povečanju in zmanjšanju odmerka, in vsakič, ko ste zaskrbljeni.
English: It is supplied in a 60 ml or 250 ml amber glass bottle in a cardboard carton.
Slovenian: Dobavljena je v 60-mililitrski ali 250mililitrski steklenici jantarjeve barve v kartonski škatli.
English: The primary analysis population was revised to only comprise patients with an age of 3 -16 years which rendered 19 patients in the glycopyrrolate oral solution group an 17 in the placebo group.
Slovenian: Populacija za primarno analizo je bila revidirana tako, da so jo sestavljali le bolniki, stari od 3 do 16 let, pri kateri je bilo 19 bolnikov v skupini, ki je uporabljala peroralno raztopino glikopirolata, 17 bolnikov pa je bilo v kontrolni skupini.
English: Mild to moderate renal impairment (eGFR <90 - ≥30 ml/min/1.73m2) doses should be reduced by 30% (see Table 2).
Slovenian: Pri blagi do zmerni okvari ledvic (eGFR < 90-≥ 30 ml/min/1,73m2) je treba odmerke zmanjšati za 30 % (glejte preglednico 2).
English: An AUC0-6 h of 8.64 µg.h/L was observed after 6 µg/kg i.v.
Slovenian: Po intravenskem odmerku glikopironija 6 µg/kg je bil opažen AUC0-6 h v višini 8,64 µg.h/l.
English: Gently pull down the plunger to the correct level (see Tables 1 and 2 for the correct dose).
Slovenian: Previdno povlecite bat na pravilno raven (za pravilen odmerek glejte preglednici 1 in 2).
English: Since reduced salivation can increase the risk of oral cavities and periodontal diseases, it is important that patients receive adequate daily dental hygiene and regular dental health checks.
Slovenian: Ker se lahko zaradi manjšega slinjenja poveča tveganje bolezni ustne votline in parodontalnih bolezni, je pomembno, da se zagotovijo ustrezna dnevna zobna higiena bolnikov in redni zobozdravniški pregledi.
English: dose is renally excreted within the first 24 hours.
Slovenian: Približno 65 % intravenskega odmerka se izloči skozi ledvice v prvih 24 urah.
English: Impaired hepatic function is not expected to affect the pharmacokinetics of glycopyrronium since the majority of the medicinal product is eliminated through the kidneys.
Slovenian: Motnje delovanja jeter ne bi smele vplivati na farmakokinetiko glikopironija, saj se večina zdravila izloči skozi ledvice.
English: Antimuscarinics such as glycopyrronium should be used with caution in patients with gastrooesophageal reflux disease, pre-existing constipation and diarrhoea.
Slovenian: Antimuskarinska zdravila, kot je glikopironij, je treba previdno uporabljati pri bolnikih z gastroezofagealnim refluksom, obstoječo zaprtostjo in drisko.
English: Due to the low likelihood of benefit and the known adverse effect profile, Sialanar should not be given to children with mild to moderate sialorrhoea.
Slovenian: Zaradi majhne verjetnosti, da bo zdravilo koristno, in znanega profila neželenih učinkov se zdravilo ne sme uporabljati pri otrocih z blago do zmerno sialorejo.
English: BCM Ltd Nottingham NG90 2PR United Kingdom
Slovenian: Izdelovalec BCM Ltd Nottingham NG90 2PR Velika Britanija
English: This leaflet was last revised in Month YYYY Other sources of information
Slovenian: Navodilo je bilo nazadnje revidirano dne mesec LLLL
English: Glycopyrronium competitively inhibits cholinergic muscarinic receptors in salivary glands and other peripheral tissues, thus indirectly reducing the rate of salivation.
Slovenian: Glikopironij kompetitivno zavira holinergične muskarinske receptorje v žlezah slinavkah in drugem perifernem tkivu, s čimer posredno zmanjšuje slinjenje.
English: After evaluating the event, the prescriber will decide if treatment should remain stopped or if this should continue at a lower dose.
Slovenian: Zdravnik bo ocenil učinke in sprejel odločitev, ali je treba prenehati z zdravljenjem ali naj se zdravljenje nadaljuje z manjšim odmerkom.
English: The bottle contains 60 ml or 250 ml of oral solution.
Slovenian: Steklenička vsebuje 60 ml ali 250 ml peroralne raztopine.
English: If you are not sure if any of the above applies to your child, talk to a doctor or pharmacist before giving Sialanar.
Slovenian: Če niste prepričani, ali zgoraj navedeno velja za vašega otroka, se pred uporabo zdravila Sialanar posvetujte z zdravnikom ali farmacevtom.
English: • inflammation and swelling of sinuses (sinusitis)
Slovenian: • vnetje in otekanje sinusov (sinusitis)
English: The bioavailability of oral glycopyrronium in children was between that of adults under fed and fasted conditions.
Slovenian: Biološka razpoložljivost peroralnega glikopironija pri otrocih je bila med biološko razpoložljivostjo pri odraslih, ko niso bili tešči in ko so bili tešči.
English: Urinary retention.
Slovenian: Zastajanje urina.
English: o The Summary of Product Characteristics o Information about the drug utilisation study to monitor and assess effectiveness of additional risk minimisation measures for anticholinergic side effects that may be dose dependent and the importance of contributing to such a study o Remarks on the importance of reporting on specific adverse drug reactions, namely: urinary retention, constipation, pneumonia, allergic reactions, dental caries, cardiovascular effects, CNS effect and overheating o The Prescriber checklist, which shall contain the following key messages:
Slovenian: o povzetek glavnih značilnosti zdravila; o informacije o študiji o uporabi zdravil za spremljanje in ocenjevanje učinkovitosti dodatnih ukrepov za zmanjševanje tveganj antiholinergičnih neželenih učinkov, ki so lahko odvisni od odmerka, ter o pomembnosti sodelovanja v taki študiji; o opombe o pomembnosti poročanja specifičnih neželenih učinkov zdravila, in sicer zastajanja urina, zaprtosti, pljučnice, alergijskih reakcij, zobnega kariesa, učinkov na kardiovaskularni sistem, učinkov na centralni živčni sistem in pregrevanja; o kontrolni seznam za zdravnika, ki predpiše zdravilo, na katerem so navedena naslednja ključna sporočila:
English: Glycopyrronium can cause thickening of secretions, which may increase the risk of respiratory infection and pneumonia.
Slovenian: Glikopironij lahko povzroči zgoščevanje izločkov, kar lahko poveča tveganje okužbe dihal in pljučnice.
English: In rats at higher doses (1500-2000 mg/kg) tremors, clonic and tonic convulsions and laboured breathing were observed prior to death, resulting from respiratory failure.
Slovenian: Pri podganah so bili pri višjih odmerkih (1.500-2.000 mg/kg) pred smrtjo zaradi respiratorne odpovedi opaženi tremorji, klonične in tonične konvulzije ter težko dihanje.
English: Dosing should be at least one hour before or at least two hours after meals or at consistent times with respect to food intake.
Slovenian: Zdravilo je treba vzeti vsaj eno uro pred obrokom ali dve uri po njem oziroma ob enakem času glede na zaužito hrano.
English: Reduced salivation can increase the risk of dental disease therefore the child's teeth should be brushed daily and they should have regular dental health checks.
Slovenian: Zaradi manjšega slinjenja je lahko tveganje zobnih bolezni večje, zato vsak dan ščetkajte otrokove zobe in zagotovite redne zobozdravniške preglede.
English: Where the child's specific needs determine that co-administration with food is required, dosing of the medicinal product should be consistently performed during food intake.
Slovenian: Če je treba zaradi posebnih otrokovih potreb zdravilo jemati s hrano, je treba zdravilo dosledno jemati med obrokom.
English: Glycopyrronium belongs to a group of medicines known as quaternary ammonium anticholinergics, which are agents that block or reduce the transmission between nerve cells.
Slovenian: Glikopironij spada v skupino zdravil, ki so znana kot kvaterni amonijevi antiholinergiki, tj. snovi, ki preprečijo ali zmanjšajo prenos med živčnimi celicami.
English: • to provide information on the management and minimisation of anticholinergic reactions, especially on management of constipation, urinary retention, pneumonia, risk of overheating, CNS effects or overdose; and on allergic reactions.
Slovenian: • zagotoviti informacije o obvladovanju in zmanjševanju antiholinergičnih učinkov, zlasti o ravnanju pri zaprtosti, zastajanju urina, pljučnici, tveganju pregrevanja, učinkih na centralni živčni sistem ali prevelikem odmerjanju, ter o alergičnih reakcijah.
English: Monitoring by physicians and caregivers is required with adherence to the management instructions below:
Slovenian: Zdravniki in skrbniki jih morajo spremljati ter pri tem upoštevati naslednja navodila za njihovo obvladovanje:
English: In the event of constipation, urinary retention or pneumonia treatment should be stopped and the prescribing physician contacted.
Slovenian: V primeru zaprtosti, zastajanja urina ali pljučnice je treba prekiniti zdravljenje in se posvetovati z zdravnikom, ki je predpisal zdravilo.
English: Gently pull down the plunger to the correct level (see the tables for the correct dose).
Slovenian: Previdno povlecite bat na pravilno raven (za pravilen odmerek glejte preglednici).
English: Sialanar is used to treat excessive production of saliva (sialorrhoea) in children and adolescents aged 3 years and older.
Slovenian: Zdravilo Sialanar se uporablja za zdravljenje prekomernega izločanja sline (sialoreje) pri otrocih in mladostnikih, starih 3 leta ali več.
English: Medicinal products with anticholinergic properties (e.g. antihistamines, antidepressants) may cause cumulative parasympatholytic effects including dry mouth, urinary retention, constipation and confusion, and an increased risk of anticholinergic intoxication syndrome.
Slovenian: Zdravila z antiholinergičnimi lastnostmi (npr. antihistaminiki in antidepresivi) lahko povzročijo kumulativne parasimpatolitske učinke, vključno s suhimi usti, zastajanjem urina, zaprtostjo in zmedenostjo, ter povečajo tveganje sindroma zastrupitve z antiholinergiki.
English: Severe renal impairment (eGFR <30 ml/min/1.73m2), including those with end-stage renal disease requiring dialysis.
Slovenian: Huda okvara ledvic (eGFR < 30 ml/min/1,73m2), vključno s končno ledvično odpovedjo, pri kateri je potrebna dializa.
English: • Difficulty in passing urine (urinary retention) - very common
Slovenian: • težave pri uriniranju (zastajanje urina) - zelo pogosti
English: No effects on fertility were observed in male rats.
Slovenian: Pri samcih podgan niso bili opaženi učinki na plodnost.
English: There is no placebo or comparator controlled data beyond 8 weeks.
Slovenian: Ni podatkov iz kliničnih preskušanj, kontroliranih s placebom ali primerjalnim zdravilom, za zdravljenje, daljše od osmih tednov.
English: Remove the oral syringe.
Slovenian: Odstranite brizgo za peroralno odmerjanje.
English: Glycopyrronium is a quaternary ammonium antimuscarinic with peripheral effects similar to those of atropine.
Slovenian: Glikopironij je kvaterno amonijevo antimuskarinsko zdravilo s perifernimi učinki, ki so podobni učinkom atropina.
English: • to provide information on the administration of Sialanar, specifically on the accurate use of the prescribed dosing, the time of administration before the meals, the avoidance of the administration of Sialanar with high fat meals, use of the oral syringe and the need to complete the administration table at the end of the reminder card for patient's carer to remind the carer of the correct dose to be given to the child.
Slovenian: • zagotoviti informacije o uporabi zdravila Sialanar, zlasti o uporabi pravilnega predpisanega odmerka, času uporabe pred obroki, izogibanju uporabe zdravila Sialanar pri obrokih z visoko vsebnostjo maščob, uporabi brizge za peroralno odmerjanje in potrebi po izpolnitvi preglednice o dajanju zdravila na koncu opozorilne kartice za skrbnika, da se ga opomni, da mora otroku dati pravilen odmerek;
English: At the week 24/exit visit, 52.3% (95% confidence interval 43.7-60.9) of patients (n=130) had an at least three-point decrease in mTDS from baseline and were classified as responders to treatment with oral glycopyrrolate solution..
Slovenian: V 24. tednu/pri zadnjem obisku je bilo pri 52,3 % (95odstotni interval zaupanja 43,7-60,9) bolnikov (n = 130) doseženo zmanjšanje v višini vsaj treh točk po mTDS glede na osnovo, zato so se obravnavali kot bolniki, ki so se odzvali na zdravljenje s peroralno raztopino glikopirolata.
English: Check you have the correct level.
Slovenian: Preverite, ali je raven pravilna.
English: Antimuscarinics are competitive inhibitors of the actions of acetylcholine at the muscarinic receptors of autonomic effector sites innervated by parasympathetic (cholinergic postganglionic) nerves.
Slovenian: Antimuskarinska zdravila so kompetitivni zaviralci delovanja acetilholina na muskarinske receptorje avtonomnih efektorjev, ki so oživčeni s parasimpatičnimi (holinergičnimi postganglijskimi) živci.
English: The most common anticholinergic adverse reactions in the placebo-controlled studies (see section 5.1) related to the gastrointestinal system and were dry mouth, constipation, diarrhoea and vomiting, all of which occurred at a rate of ≥15%.
Slovenian: Najpogostejši antiholinergični neželeni učinki pri s placebom kontroliranih študijah (glejte poglavje 5.1) so povezani s prebavili ter so suha usta, zaprtost, driska in bruhanje, ki so se pojavili pri najmanj 15 % bolnikov.
English: p <0.0001 In addition, 84% of physicians and 100% of parents/caregivers regarded glycopyrrolate as worthwhile compared with 41% and 56%, respectively, for placebo (p≤0.014).
Slovenian: Poleg tega je 84 % zdravnikov in 100 % staršev/negovalcev menilo, da je glikopirolat koristen, medtem ko je bilo pri placebu tega mnenja 41 % zdravnikov in 56 % staršev/skrbnikov (p ≤ 0,014).
English: • insomnia (difficulty in sleeping)
Slovenian: • nespečnost (težave s spanjem)
English: • corticosteroids, used to treat inflammatory diseases
Slovenian: • kortikosteroidi, ki se uporabljajo za zdravljenje vnetnih bolezni.
English: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000
Slovenian: Poleg tega je pogostnost vsakega neželenega učinka opredeljena kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: dose is relatively high at between 0.54 ± 0.14 L/h/kg and 1.14 ± 0.31 L/h/kg.
Slovenian: Skupni očistek zdravila iz telesa po intravenskem odmerku je razmeroma visok in znaša od 0,54 ± 0,14 l/h/kg do 1,14 ± 0,31 l/h/kg.
English: Concomitant use to be considered with caution Concomitant use of the following medicinal products should be considered with caution:
Slovenian: Previdna sočasna uporaba z drugimi zdravili Bodite previdni pri sočasni uporabi zdravila z naslednjimi zdravili:
English: The materials should also cover the need to avoid exposure to hot weather and overheating; risk of caries associated to reduced salivation and need for regular dental hygiene and dental checks and the requirement to check the pulse at regular intervals.
Slovenian: V gradivu bi moralo biti navedeno tudi, da se je treba izogibati izpostavljanju bolnika vročemu vremenu in pregrevanju, da obstaja tveganje nastanka kariesa zaradi manjšega slinjenja, da so potrebni redna zobna higiena in zobozdravniški pregledi ter da je treba redno preverjati srčni utrip.
English: • raised pressure in the eye (which might cause glaucoma); photophobia (sensitivity to light);
Slovenian: • zvišan očesni pritisk (lahko povzroči glavkom), fotofobija (občutljivost na svetlobo), suhe oči
English: Glycopyrronium has little effect on cholinergic stimuli at nicotinic acetylcholine receptors, on structures innervated by postganglionic cholinergic neurons, and on smooth muscles that respond to acetylcholine but have no cholinergic innervation.
Slovenian: Glikopironij ima majhen učinek na holinergične dražljaje na nikotinske acetilholinske receptorje, na strukture, oživčene s holinergičnimi postganglijskimi nevroni, in na gladke mišice, ki se odzivajo na acetilholin, vendar niso oživčene s holinergičnimi živci.
English: Thirtyeight patients aged 3-23 years weighing at least 27 lb (12.2 kg) with severe drooling (clothing damp 5-7 days/week) were randomized to eight-weeks treatment with glycopyrronium (n = 20), 20-100 μg/kg (not exceeding 3 mg in total) three times a day, or matching placebo (n = 18).
Slovenian: 38 bolnikov, starih od 3 do 23 let, ki so tehtali vsaj 27 funtov (12,2 kg) in so se zelo slinili (oblačila so bila vlažna od 5 do 7 dni na teden), je bilo naključno izbranih za osemtedensko zdravljenje z glikopironijem (n = 20) v odmerku 20-100 μg/kg (skupaj največ 3 mg) trikrat na dan ali ustreznim placebom (n = 18).
English: − If you have any further questions, ask your doctor or pharmacist.
Slovenian: − Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.
English: Topiramate: glycopyrronium may potentiate the effects of oligohidrosis and hyperthermia associated with the use of topiramate, particularly in pediatric patients;
Slovenian: Topiramat: glikopironij lahko poveča učinke premajhnega potenja in hipertermije, povezane z uporabo topiramata, zlasti pri pediatričnih bolnikih.
English: If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
Slovenian: Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom ali farmacevtom.
English: • Fever (pyrexia)
Slovenian: • vročina (pireksija)
English: In the event of a known anticholinergic adverse event occurring when the dose is increased, the dose should be reduced to the previous lower dose and the event monitored.
Slovenian: Če se pri povečanju odmerka pojavi znan antiholinergičen neželeni učinek, je treba odmerek zmanjšati na prejšnji nižji odmerek in spremljati dogajanje.
English: If you stop giving Sialanar to your child
Slovenian: Če otroku prenehate dajati zdravilo Sialanar
English: • opioids used to treat severe pain
Slovenian: • opioidi, ki se uporabljajo za zdravljenje hude bolečine;
English: The safety profile is further characterised by other symptoms, related to the anticholinergic effects at a rate of ≥15%, including urinary retention, flushing and nasal congestion.
Slovenian: Za varnostni profil so značilni tudi drugi simptomi, povezani z antiholinergičnimi učinki, ki so se pojavili pri najmanj 15 % bolnikov, vključno z zastajanjem urina, vročinskimi oblivi in zamašenim nosom.
English: Neuroleptics/antipsychotics: the effects of active substances such as phenothiazines, clozapine and haloperidol may be potentiated.
Slovenian: Nevroleptiki/antipsihotiki: učinki učinkovin, kot so na primer fenotiazini, klozapin in haloperidol, so lahko večji.
English: Hold the oral syringe in place and turn the bottle upside down.
Slovenian: Držite brizgo za peroralno odmerjanje in obrnite steklenico z brizgo navzdol.
English: Chronic oral administration of glycopyrronium at doses of 4, 16 and 64 mg/kg for up to 27 weeks in dogs produced mydriasis, cycloplegia, xerostomia, emesis, occasional lacrimation, injection of sclera and rhinorrhoea.
Slovenian: Kronična peroralna uporaba glikopironija pri psih po odmerkih 4, 16 in 64 mg/kg, ki je trajala do 27 tednov, je povzročila midriazo, paralizo ciliarne mišice, kserostomijo, bruhanje, občasno solzenje, pordele oči in rinorejo.
English: Non-clinical data, including genotoxicity or carcinogenicity studies have not been performed for
Slovenian: Predklinični podatki, vključno s študijami genotoksičnosti ali kancerogenosti, niso bili pridobljeni za zdravilo Sialanar.
English: • urgent need to urinate;
Slovenian: • nujna potreba po uriniranju
English: Dosing table for children and adolescents with normal renal function.
Slovenian: Preglednica za odmerjanje zdravila pri otrocih in mladostnikih z normalno ledvično funkcijo Telesna masa
English: Concomitant treatment with (see section 4.5);
Slovenian: Sočasno zdravljenje z (glejte poglavje 4.5):
English: History of intestinal obstruction, ulcerative colitis, paralytic ileus, pyloric stenosis and myasthenia gravis.
Slovenian: Pretekle črevesne zapore, ulcerozni kolitis, paralitični ileus, pilorična stenoza in miastenija gravis.
English: • Involuntary eye movement (nystagmus)
Slovenian: • nenadzorovano premikanje oči (nistagmus)
English: Glycopyrronium is cleared predominantly from the systemic circulation by renal excretion and hepatic impairment is not thought to result in a clinically relevant increase in systemic exposure of glycopyrronium.
Slovenian: Glikopironij se iz sistemskega krvnega obtoka očisti zlasti z izločanjem skozi ledvice, okvara jeter pa naj ne bi povzročila klinično pomembnega zvečanja sistemske izpostavljenosti glikopironiju.
English: Sialanar must not be given if the patient is pregnant (or could be pregnant), or is breast-feeding (see section 2 ‘Do not give').
Slovenian: Zdravilo Sialanar se ne sme uporabljati pri nosečnicah (ali potencialnih nosečnicah) ali ob dojenju (glejte poglavje 2 Otrok ali mladostnik ne sme uporabljati zdravila Sialanar:).
English: Overdose of glycopyrronium can result in anticholinergic syndrome, produced by the inhibition of cholinergic neurotransmission at muscarinic receptor sites.
Slovenian: Preveliko odmerjanje glikopironija lahko povzroči antiholinergični sindrom, ki nastane zaradi zaviranja holinergičnega živčnega prenosa pri muskarinskih receptorjih.
English: There are limited data available relating to interactions with other medicinal products in the paediatric age group.
Slovenian: Za pediatrično starostno skupino so na voljo le omejeni podatki o medsebojnem delovanju z drugimi zdravili.
English: • Agitation
Slovenian: • vznemirjenost