FrancophonIA/ELRC3.0 huggingface dataset:
English: The efficacy of the medicinal product should be balanced against the adverse reactions and the dose monitored regularly and adjusted as necessary.
Slovenian: Učinkovitost zdravila je treba uravnovesiti z neželenimi učinki, odmerke pa je treba redno spremljati in po potrebi prilagoditi.
English: • skeletal muscle relaxants (botulinum toxin)
Slovenian: • mišični relaksanti (botulinski toksin);
English: • Swelling mainly of the tongue, lips, face or throat (possible signs of angioedema) - frequency not known
Slovenian: • Otekanje, zlasti jezika, ustnic, obraza ali grla (morebitni znaki angioedema) - pogostnost ni znana
English: Due to the lack of long term safety data, Sialanar is recommended for short -term intermittent use (see section 4.4)
Slovenian: Zaradi pomanjkanja podatkov o varnosti pri dolgoročni uporabi zdravila Sialanar se priporoča njegova kratkoročna uporaba s prekinitvami (glejte poglavje 4.4).
English: • a high temperature (fever)
Slovenian: • visoko temperaturo (vročino),
English: The carer should be advised to measure the pulse rate if the child seems unwell and report very fast or very slow heart rate.
Slovenian: Skrbnik mora izmeriti hitrost srčnega utripa, če se otrok ne počuti dobro, in sporočiti zelo hiter ali zelo počasen srčni utrip.
English: It is possible that prolonged absorption after oral administration translates into elimination being faster than absorption (known as flip-flop kinetics, characterized by Ka < Ke).
Slovenian: Možno je, da daljša absorpcija po peroralni uporabi povzroči, da je izločanje hitrejše od absorpcije (tj. flip-flop učinek, za katerega je značilno, da je Ka < Ke).
English: The single dose toxicity of glycopyrronium has been tested in a range of investigations, although only limited experimental details are available.
Slovenian: Toksičnost enkratnega odmerka glikopironija je bila preskušena s številnimi preskušanji, vendar so na voljo le omejeni podrobni podatki o preskusih.
English: Clinical manifestations are caused by CNS effects, peripheral nervous system effects, or both.
Slovenian: Klinične manifestacije povzročajo učinki na centralni živčni sistem, učinki na periferni živčni sistem ali oboje.
English: If continuous treatment is needed (eg in a palliative setting) or the treatment is repeated intermittently (e.g. in the non palliative setting treating chronic disease) benefits and risks should be carefully considered on a case by case basis and treatment should be closely monitored.
Slovenian: Če je potrebno stalno zdravljenje (npr. pri paliativni oskrbi) ali če se zdravljenje ponovi po prekinitvi (npr. pri nepaliativni oskrbi za zdravljenje kronične bolezni), je treba v vsakem primeru posebej skrbno proučiti koristi in tveganja, zdravljenje pa skrbno spremljati.
English: High fat food should be avoided.
Slovenian: Izogibati se je treba hrani z visoko vsebnostjo maščob.
English: Safety in breast-feeding has not been established.
Slovenian: Varnost zdravila ob dojenju ni bila dokazana.
English: Sialanar is not recommended in children below the age of 3 years since there is very limited data on the efficacy and safety of glycopyrronium in this age group.
Slovenian: Uporaba zdravila Sialanar se odsvetuje pri otrocih, mlajših od 3 let, saj ni veliko podatkov o učinkovitosti in varnosti glikopironija pri tej starostni skupini.
English: Younger children may be more susceptible to adverse events and this should be borne in mind when any dose adjustments are carried out.
Slovenian: Mlajši otroci so lahko dovzetnejši za neželene učinke, kar je treba upoštevati pri morebitnem prilagajanju odmerkov.
English: There are no data on the effects of Sialanar on male or female fertility.
Slovenian: Ni podatkov o učinkih zdravila Sialanar na plodnost moških ali žensk.
English: This medicine is formulated as an oral formulation and a dose specifically for use in children and adolescents aged 3 years and older.
Slovenian: To zdravilo je formulirano kot peroralni pripravek in odmerek, ki je posebej namenjen uporabi pri otrocih in mladostnikih, starih 3 leta ali več.
English: In particular taking Sialanar with the following medicines can affect the way Sialanar or the listed medicine works or can increase the risk of side effects:
Slovenian: Zlasti jemanje zdravila Sialanar z naslednjimi zdravili lahko vpliva na to, kako zdravilo Sialanar ali navedeno zdravilo učinkuje, in lahko poveča tveganje neželenih učinkov:
English: Insert the syringe adaptor with the hole into the neck of the bottle (this may have been done already by the pharmacist).
Slovenian: V vrat steklenice vstavite nastavek za brizgo (to lahko stori že farmacevt).
English: As this exceeds the glomerular filtration rate and it appears that more than 50% of the dose is excreted unchanged in the urine, it is probable that the renal elimination of glycopyrronium involves both glomerular filtration and proximal tubular secretion by the base secretory mechanism.
Slovenian: Ker to presega hitrost glomerulne filtracije in ker se zdi, da se več kot 50 % odmerka izloči nespremenjenega z urinom, je verjetno, da izločanje glikopironija skozi ledvice vključuje tako glomerulno filtracijo kot izločanje skozi proksimalne tubule osnovnega mehanizma za izločanje.
English: • severe allergic reaction (angioedema); signs include swelling mainly of the tongue, lips, face or throat
Slovenian: • huda alergijska reakcija (angioedem), med znaki so zlasti otekanje jezika, ustnic, obraza ali grla
English: BCM Limited
Slovenian: BCM Limited Thane Road
English: EU/1/16/1135/001 - 250 ml bottle EU/1/16/1135/002 - 60 ml bottle
Slovenian: EU/1/16/1135/001 - 250 ml steklenička EU/1/16/1135/002 - 60 ml steklenička
English: The child should be monitored at regular intervals (at least every 3 months) to check that Sialanar is still the right treatment for them.
Slovenian: Otroka je treba redno spremljati (vsaj vsake tri mesece), da se preveri, ali je zdravilo Sialanar še vedno primerno zanj.
English: Baseline characteristics (age, weight, gender and race) do not affect the pharmacokinetics of glycopyrronium.
Slovenian: Izhodiščne značilnosti (starost, telesna masa, spol in rasa) ne vplivajo na farmakokinetiko glikopironija.
English: Dose titrations should be conducted in discussion with the carer to assess both efficacy and undesirable effects until an acceptable maintenance dose is achieved.
Slovenian: Titriranje odmerka je treba izvajati v sodelovanju s skrbnikom, da se ocenijo učinkovitost in neželeni učinki, dokler se ne določi sprejemljiv vzdrževalni odmerek.
English: Extrapolation of safety margins to the paediatric population is not possible, as no exposure data are available from repeated dose toxicology studies and no studies in juvenile animals have been performed with glycopyrronium.
Slovenian: Varnostnih mej ni mogoče ekstrapolirati na pediatrično populacijo, ker niso na voljo podatki o izpostavljenosti iz toksikoloških študij s ponavljajočim odmerkom in ker niso bile izvedene študije uporabe glikopironija pri mladih živalih.
English: Sialanar has moderate influence on the ability to drive and use machines.
Slovenian: Zdravilo Sialanar ima zmeren vpliv na sposobnost vožnje in upravljanja strojev.
English: 0.71 points (SD: 2.14; 95% CI: -0.43-1.84)
Slovenian: 0,71 točke (SD: 2,14, 95 %, CI: -0,43-1,84)
English: The child's doctor may decide to stop treatment with Sialanar if side effects cannot be managed by reducing the dose.
Slovenian: Otrokov zdravnik lahko sprejme odločitev, da bo prenehal zdravljenje z zdravilom Sialanar, če neželenih učinkov ni mogoče obvladovati z zmanjšanjem odmerka.
English: • antihistamines, used to treat some allergies
Slovenian: • antihistaminiki, ki se uporabljajo za zdravljenje nekaterih alergij;
English: Read all of this leaflet carefully before your child starts taking this medicine because it contains important information for you.
Slovenian: Preden otrok začne uporabljati zdravilo, natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: • Thirst in hot weather
Slovenian: • žeja v vročem vremenu
English: − is allergic to glycopyrronium or any of the other ingredients of this medicine (listed in section
Slovenian: − če je alergičen na glikopironij ali katero koli sestavino tega zdravila (navedeno v poglavju 6),
English: Do not use this medicine after the expiry date, which is stated on the label after EXP: The expiry date refers to the last day of that month.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki poleg oznake „EXP“.
English: Sialanar should be prescribed by physicians experienced in the treatment of paediatric patients with neurological disorders.
Slovenian: Zdravilo Sialanar mora predpisati zdravnik, ki ima izkušnje z zdravljenjem pediatričnih bolnikov z nevrološkimi motnjami.
English: It is important that the dose is given at consistent times in relation to food intake.
Slovenian: Pomembno je, da odmerek vzame ob enakem času glede na zaužito hrano.
English: • neuroleptics/antipsychotics (clozapine, haloperidol, phenothiazine), used to treat some mental illnesses
Slovenian: • nevroleptiki/antipsihotiki (klozapin, haloperidol, fenotiazin), ki se uporabljajo za zdravljenje nekaterih duševnih bolezni;
English: Sialorrhoea (drooling or excessive salivation) is a common symptom of many diseases of the nerves and muscles.
Slovenian: Sialoreja (prekomerno slinjenje) je pogost simptom pri mnogih živčnih in mišičnih boleznih.
English: The elderly have a longer elimination half-life and reduced medicinal product clearance as well as limited data to support efficacy in short-term use.
Slovenian: Razpolovna doba izločanja starejših je daljša, očistek zdravila pa manjši, poleg tega pa ni veliko podatkov o dokazani učinkovitosti zdravila pri kratkoročni uporabi.
English: The long-term efficacy and safety of Sialanar has not been studied beyond 24 weeks of use.
Slovenian: Dolgoročna učinkovitost in varnost zdravila Sialanar nista bili preskušeni pri zdravljenju, daljšem od 24 tednov.
English: Adverse reactions are more common with higher doses and prolonged use.
Slovenian: Neželeni učinki so pogostejši pri večjih odmerkih in daljši uporabi.
English: Zeller et al 2012a evaluated the efficacy of glycopyrronium bromide oral solution (1 mg/5 mL) in managing problem drooling associated with cerebral palsy and other neurologic conditions.
Slovenian: (2012a) so ocenili učinkovitost peroralne raztopine glikopironijevega bromida (1 mg/5 ml) pri obvladovanju problematičnega slinjenja, povezanega s cerebralno paralizo in drugimi nevrološkimi motnjami.
English: Glycopyrronium is known to have an effect on heart rate and blood pressure at doses used during anaesthesia although clinical trials in children with chronic drooling have not shown this effect.
Slovenian: Znano je, da glikopironij vpliva na srčni utrip in krvni tlak pri odmerkih, ki se uporabljajo med anestezijo, čeprav klinična preskušanja pri otrocih s kroničnim slinjenjem niso pokazala tega učinka.
English: Prior to launch of Sialanar in each Member State, the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational materials, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Slovenian: Imetnik dovoljenja za promet z zdravilom se mora pred prihodom zdravila Sialanar na trg v posamezni državi članici z nacionalnim pristojnim organom dogovoriti o vsebini in obliki izobraževalnega gradiva, vključno s sredstvi obveščanja, načini razdeljevanja in vsemi drugimi vidiki programa.
English: Effective contraception should be considered prior to treating women of childbearing age, where appropriate.
Slovenian: Ženske v rodni dobi naj pred zdravljenjem začnejo uporabljati učinkovito kontracepcijo, kadar je to potrebno.
English: Responder rate was defined as at least a 3-point improvement in modified Teacher's Drooling Scale (mTDS).
Slovenian: Stopnja odziva je bila opredeljena kot izboljšanje v višini vsaj treh točk po prilagojeni lestvici slinjenja Teacher's Drooling Scale (mTDS).
English: It is important that the carer checks the dose volume in the syringe before administration.
Slovenian: Pomembno je, da skrbnik pred uporabo preveri količino odmerka v brizgi.
English: Volume of distribution is somewhat higher in the paediatric population(s), in the range 1.31 to 1.83 L/kg.
Slovenian: Volumen porazdelitve je nekoliko višji pri pediatrični populaciji, saj znaša med 1,31 l/kg in 1,83 l/kg.
English: Analyses of population pharmacokinetic data from healthy adults and children with cerebral palsy-associated chronic moderate to severe drooling who received glycopyrronium (route of administration and dosages not specified) did not demonstrate linear pharmacokinetics of the medicinal product.
Slovenian: Analize farmakokinetičnih podatkov populacije pri zdravih odraslih in otrocih z zmernim do hudim slinjenjem, povezanim s cerebralno paralizo, ki so prejeli glikopironij (pot uporabe in odmerki niso bili določeni), niso pokazale linearne farmakokinetike zdravila.
English: Management of important anticholinergic side effects The carer should stop treatment and seek advice from the prescriber in the event of:
Slovenian: Obvladovanje pomembnih antiholinergičnih neželenih učinkov Skrbnik mora prekiniti zdravljenje in se posvetovati z zdravnikom, ki je predpisal zdravilo, v primeru:
English: Other medicines and Sialanar
Slovenian: Druga zdravila in zdravilo Sialanar
English: Dose titration should be continued until efficacy is balanced with undesirable effects and amended up or down as appropriate, to a maximum individual dose of 64 micrograms/kg body weight glycopyrronium or 6 ml (1.9 mg glycopyrronium, equivalent to 2.4 mg glycopyrronium bromide) three times a day, whichever is less.
Slovenian: Titriranje odmerka je treba nadaljevati, dokler se učinkovitost ne uravnovesi z neželenimi učinki, in po potrebi prilagoditi navzgor ali navzdol do največjega posamičnega odmerka glikopironija 64 mikrogramov/kg telesne mase ali 6 ml (1,9 mg glikopironija, kar ustreza 2,4 mg glikopironijevega bromida) trikrat na dan, kar koli je manj.
English: The adverse event profile was consistent with the one seen with anticholinergics (see section 4.4 and 4.8).
Slovenian: Profil neželenih učinkov je bil skladen s profilom pri antiholinergikih (glejte poglavji 4.4 in 4.8).
English: Symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and adolescents aged 3 years and older with chronic neurological disorders.
Slovenian: Simptomatsko zdravljenje hude sialoreje (kroničnega patološkega slinjenja) pri otrocih in mladostnikih, starih 3 leta ali več, s kroničnimi nevrološkimi motnjami.
English: anticholinergics;
Slovenian: antiholinergiki.
English: There is limited clinical trial evidence on the use of glycopyrronium in the adult population with pathological drooling.
Slovenian: Ne obstaja veliko dokazov iz kliničnih preskušanj o uporabi glikopironija pri odrasli populaciji s patološkim slinjenjem.
English: Mild to moderate sialorrhoea
Slovenian: Blaga do zmerna sialoreja
English: • heart disease, heart failure, irregular heartbeats or high blood pressure
Slovenian: • bolezen srca, srčno popuščanje, neenakomeren srčni utrip ali visok krvni tlak,
English: If you forget to give Sialanar
Slovenian: Če ste pozabili dati zdravilo Sialanar
English: After use, leave the syringe adaptor in the neck of the bottle.
Slovenian: Po uporabi pustite nastavek za brizgo v vratu steklenice.
English: Primary efficacy endpoint was responder rate, defined as percentage showing ≥3-point improvement on the modified Teacher's Drooling Scale (mTDS).
Slovenian: Končni cilj primarne učinkovitosti je bila stopnja odziva, opredeljena kot odstotek, ki je prikazoval izboljšanje v višini treh točk ali več po prilagojeni lestvici slinjenja Teacher's Drooling Scale (mTDS).
English: Section 4 includes possible side effects related to the use of Sialanar.
Slovenian: V poglavju 4 so navedeni morebitni neželeni učinki, povezani z uporabo zdravila Sialanar.
English: If the event does not resolve treatment should be discontinued.
Slovenian: Če neželeni učinek ne izgine, je treba prenehati z zdravljenjem.
English: The anticholinergic effects of glycopyrronium may cause blurred vision, dizziness and other effects that may impair a patient's ability to perform skilled tasks such as driving, riding a bicycle and using machines.
Slovenian: Antiholinergični učinki glikopironija lahko povzročijo zamegljen vid, omotico in druge učinke, ki lahko zmanjšajo bolnikovo sposobnost opravljanja zahtevnih nalog, kot so vožnja, kolesarjenje in upravljanje strojev.
English: Other side effects that occur with anticholinergics but their frequency with glycopyrronium is not known
Slovenian: Drugi neželeni učinki, ki se pojavijo pri antiholinergikih, vendar njihova pogostnost pri uporabi glikopironija ni znana
English: Placebo controlled efficacy data includes patients with a treatment duration of 8 weeks.
Slovenian: Podatki o učinkovitosti iz s placebom kontroliranih kliničnih preskušanj so vključevali bolnike, ki so zdravilo uporabljali osem tednov.
English: Following the dose titration period, the child's sialorrhoea should be monitored, in conjunction with the carer at no longer than 3 monthly intervals, to assess changes in efficacy and/or tolerability over time, and the dose adjusted accordingly.
Slovenian: Po obdobju titriranja odmerka morate skupaj z skrbnikom na vsaj vsake tri mesece spremljati otrokovo sialorejo, da ocenite postopne spremembe učinkovitosti in/ali prenašanja, in odmerek ustrezno prilagoditi.
English: Clinical studies have not been conducted in patients with hepatic impairment.
Slovenian: Klinične študije niso bile opravljene pri bolnikih z okvaro jeter.
English: Sialanar is not recommended for children under 3 years of age.
Slovenian: Uporaba zdravila Sialanar ni priporočljiva pri otrocih, mlajših od 3 let.
English: Continued use of Sialanar should be discussed with the child's doctor every 3 months to check that Sialanar is still right for the child.
Slovenian: O nadaljnji uporabi zdravila Sialanar se vsake tri mesece posvetujte z otrokovim zdravnikom, da preverite, ali je zdravilo Sialanar še vedno primerno za otroka.
English: • The patient information pack should contain: o Patient information leaflet o The reminder card for patient's carer, which shall contain the following key messages:
Slovenian: Izobraževalno gradivo za bolnika mora vsebovati: o navodila za uporabo; o opozorilno kartico za skrbnika, kjer so navedena naslednja ključna sporočila:
English: Data on reproductive endpoints for glycopyrronium are very limited.
Slovenian: Podatki o reproduktivnih opozovanih dogodkih za glikopironij so zelo omejeni.
English: Sialanar is indicated for the paediatric population only.
Slovenian: Zdravilo Sialanar je indicirano le pri pediatrični populaciji.
English: The assessment of reproductive endpoints for glycopyrronium is limited (see section 5.3).
Slovenian: Ocena reproduktivnih opazovanih dogodkov za glikopironij je omejena (glejte poglavje 5.3).
English: Such effects should be discussed with the carer during treatment reviews and a dose reduction considered.
Slovenian: O takih učinkih se je treba pogovoriti s skrbnikom med pregledi zdravljenja in po potrebi zmanjšati odmerek.
English: Acute sialorrhoea may be associated with inflammation, dental infections or infections of the mouth.
Slovenian: Akutna sialoreja lahko nastane zaradi vnetja, okužb zoba ali okužb v ustni votlini.
English: The other ingredients are sodium benzoate (E211), see section 2 (Sialanar contains sodium and benzoate salt), raspberry flavouring (containing propylene glycol E1520), sucralose (E955), citric acid (E330) and purified water.
Slovenian: Druge sestavine so natrijev benzoat (E211), glejte poglavje 2 (Sialanar vsebuje natrijevo in benzoat), aroma maline (vsebuje propilenglikol E1520), sukraloza (E955), citronska kislina (E330) in prečiščena voda.
English: Adverse reactions reported in the literature for trials using glycopyrronium for sialorrhoea in the paediatric population (including 2 placebo controlled trials, an uncontrolled safety study using glycopyrronium for a 6 month period, and 3 supportive studies with adverse event data in the target population) are listed by MedDRA system organ class (Table 3).
Slovenian: Neželeni učinki iz literature za klinična preskušanja, pri katerih je bil glikopironij uporabljen za sialorejo pri pediatrični populaciji (med drugim pri dveh s placebom kontroliranih kliničnih preskušanjih, nekontrolirani študiji o varnosti zdravila, pri kateri se je proučevala šestmesečna uporaba glikopironija, in treh podpornih študijah s podatki o neželenih učinkih pri ciljni populaciji), so navedeni po organskih sistemih po MedDRA (preglednica 3).
English: Decreases >10% from the normal reference range at baseline were observed for carbon dioxide (15.1%), bicarbonate (13.3%), and creatinine (10.7%) concentrations.
Slovenian: Opaženo je bilo več kot 10-odstotno zmanjšanje glede na normalne referenčne vrednosti v izhodišču za koncentracije ogljikovega dioksida (15,1 %), bikarbonata (13,3 %) in kreatinina (10,7 %).
English: Patients and/or parents/caregivers should be counselled to ensure an acurate dose is given each time, in order to prevent the harmful consequences of anticholinergic reactions of glycopyrronium seen with dosing errors or overdose.
Slovenian: Posvetovati se je treba z bolniki in/ali starši/skrbniki, da se vedno zagotovi pravilno odmerjanje in preprečijo škodljive posledice antiholinergičnih učinkov glikopironija, ki so povezani z napačnim ali prevelikim odmerjanjem.
English: The primary route of elimination of glycopyrronium is via renal excretion, mainly as unchanged medicinal product.
Slovenian: Primarna pot izločanja glikopironija je izločanje skozi ledvice kot večinoma nespremenjeno zdravilo.
English: Modest changes in volume of distribution (Vss) and clearance (Cl) have been observed in children between 1 and 3 years of age, leading to a statistically significant shorter elimination half-life (t½, z) than that observed in younger (<1 year of age; p = 0.037) or older (>3 years of age; p = 0.042) groups.
Slovenian: Majhne spremembe v volumnu porazdelitve (Vss) in očistku (Cl) so bile opažene pri otrocih, starih od 1 do 3 let, kar je povzročilo statistično bistveno krajšo razpolovno dobo izločanja (t½, z) kot pri mlajših (otroci, mlajši od 1 leta, p = 0,037) ali starejših (otroci, starejši od 3 let, p = 0,042) skupinah.
English: In a study in healthy adults, a 2000 µg single dose of glycopyrronium bromide resulted in an AUC of 2.39 µg.h/L (fasted).
Slovenian: Pri študiji pri zdravih odraslih je pri enem odmerku zdravila glikopironijev bromid v višini 2.000 µg območje pod krivuljo (AUC) znašalo 2,39 µg.h/l (tešči).
English: Replace the closure.
Slovenian: Zamenjajte zamašek.
English: • very hot weather
Slovenian: • zelo vročega vremena,
English: Oral solution 60 ml
Slovenian: peroralna raztopina 60 ml
English: Anticholinergic effects such as urinary retention, constipation and overheating due to inhibition of sweating may be dose dependent and difficult to assess in a disabled child.
Slovenian: Antiholinergični učinki, kot so zastajanje urina, zaprtost in pregrevanje zaradi zaviranja potenja, so lahko odvisni od odmerka in jih je težko oceniti pri invalidnem otroku.
English: Contraindications of concomitant use Concomitant use of the following medicinal products is contraindicated (see section 4.3):
Slovenian: Kontraindikacije pri sočasni uporabi drugih zdravil Kontraindicirana je sočasna uporaba naslednjih zdravil (glejte poglavje 4.3):
English: Children with kidney problems may be given a lower dose.
Slovenian: Pri otrocih s težavami z ledvicami lahko uporabite manjši odmerek.
English: Although glycopyrronium has limited ability to cross the blood brain barrier, increased central nervous system effects have been reported in clinical trials (23%).
Slovenian: Čeprav je zmožnost glikopironija, da preide krvno-možgansko pregrado, omejena, so se pri kliničnih preskušanjih pojavili pogostejši učinki na centralni živčni sistem (23 %).