FrancophonIA/ELRC3.0 huggingface dataset:
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.
Maltese: It-titrazzjoni tad-doża għandha titkompla sakemm l-effikaċja tkun ibbilanċjata mal-effetti mhux mixtieqa u emendata 'l fuq jew 'l isfel kif xieraq, sa doża individwali massima ta' 64 mikrogramma/kg tal-piż tal-ġisem ta' glikopirronju jew 6 ml (1.9 mg glikopirronju, ekwivalenti għal 2.4 mg ta' bromur tal-glikopirronju) tliet darbiet kuljum, skont liema hi l-anqas.
English: Children below the age of 3 years
Maltese: Tfal taħt l-età ta' 3 snin
English: Severe renal impairment (eGFR <30 ml/min/1.73m2), including those with end-stage renal disease requiring dialysis.
Maltese: Indeboliment sever tal-kliewi (eGFR <30 ml/min/1.73m2), inkluż dawk b'mard tal-kliewi tal-aħħar stadju li jeħtieġu dijalisi.
English: • pyrexia
Maltese: • stitikezza
English: A 30% dose reduction (see Table 2) is required for patients with mild to moderate renal impairment.
Maltese: Huwa meħtieġ tnaqqis tad-doża ta' 30% (ara Tabella 2) għal pazjenti b'indeboliment ħafif sa moderat tal-kliewi.
English: If they occur, take the child to the nearest emergency medical facility and take the medicine with you.
Maltese: Jekk iseħħu, ħu littifel/tifla fl-eqreb faċilità ta' emerġenza medika u ħu l-mediċina miegħek.
English: Transient bradycardia
Maltese: Burdata varjabbli
English: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000
Maltese: Barra minn hekk, ilkategorija tal-frekwenza korrispondenti għal kull reazzjoni avversa hija bbażata fuq il-konvenzjoni li ġejja: komuni ħafna (≥ 1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: The following side effects may be a sign of severe allergic reaction.
Maltese: L-effetti sekondarji li ġejjin jistgħu jkunu sinjal ta' reazzjoni allerġika severa.
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.
Maltese: Zeller et al 2012a evalwaw l-effikaċja tas-soluzzjoni bromur tal-glikopirronju li tittieħed mill-ħalq (1 mg/5 mL) fil-ġestjoni tal-problema tat-tlegħib assoċjata mal-paraliżi ċerebrali u kundizzjonijiet newroloġiċi oħrajn.
English: Sedating antihistamines: may have additive anticholinergic effects.
Maltese: Antistamini sedattivi: jista' jkollhom effetti antikolinerġiċi addittivi.
English: Angle-closure glaucoma
Maltese: Glawkoma tat-tip angle-closure
English: Constipation is a known adverse reaction associated with anticholinergic medicinal products (30%).
Maltese: L-istitikezza hija reazzjoni avversa magħrufa assoċjata ma' prodotti mediċinali antikolinerġiċi (30%).
English: Responder rate was defined as at least a 3-point improvement in modified Teacher's Drooling Scale (mTDS).
Maltese: Ir-rata ta' dawk li rrispondew ġiet definita bħala mill-anqas titjib ta' 3 punti fil-Klassifika tatTlegħib ta' Teacher modifikata (mTDS).
English: This medicine contains 2.3 mg benzoate salt (E211) in each ml.
Maltese: Din il-mediċina fiha 2.3 mg ta' benzoate salt (E211) f'kull ml.
English: Sodium benzoate This medicinal product contains 2.3 mg sodium benzoate (E211) in each ml.
Maltese: Sodium benzoate Dan il-prodott mediċinali fih 2.3 mg ta' sodium benzoate (E211) f'kull ml.
English: Contraindications of concomitant use Concomitant use of the following medicinal products is contraindicated (see section 4.3):
Maltese: L-użu konkomitanti tal-prodotti mediċinali li ġejjin huwa kontroindikat (ara sezzjoni 4.3):
English: The following medicinal product interaction information is relevant to glycopyrronium.
Maltese: L-informazzjoni li ġejja dwar l-interazzjoni tal-prodott mediċinali hija relevanti għal glikopirronju.
English: Paediatric population - children and adolescents aged 3 years and older The dosing schedule for glycopyrronium is based on the weight of the child, starting with approximately 12.8 micrograms/kg per dose (equivalent to 16 micrograms/kg per dose glycopyrronium bromide), three times per day and increasing by the doses shown in Table 1 below, every 7 days.
Maltese: Popolazzjoni pedjatrika - tfal u adolexxenti li għandhom 3 snin u akbar L-iskeda tad-dożaġġ għal glikopirronju hija bbażata fuq il-piż tat-tifel jew tat-tifla, fejn tibda minn bejn wieħed u ieħor 12.8 mikrogrammi/kg għal kull doża (ekwivalenti għal 16-il mikrogramma/kg għal kull doża ta' bromur tal-glikopirronju), tliet darbiet kuljum u tiżdied permezz tad-dożi murija f'Tabella 1 hawn taħt, kull 7 ijiem.
English: Temper tantrum
Maltese: Tkabbir u żvilupp
English: Renal impairment Severe renal impairment (see section 4.3).
Maltese: Indeboliment tal-kliewi Indeboliment sever tal-kliewi (ara sezzjoni 4.3).
English: Opioids: active substances such as pethidine and codeine may result in additive central nervous system and gastrointestinal adverse effects, and increase the risk of severe constipation or paralytic ileus and CNS depression.
Maltese: Opjojdi: sustanzi attivi bħal pethidine u codeine jistgħu jirriżultaw f'effetti avversi addittivi tas-sistema nervuża ċentrali u gastrointestinali, u jżidu r-riskju ta' stitikezza severa jew ileus paralitiku u dipressjoni tas-CNS.
English: MM/YYYY
Maltese: • Uġigħ ta' ras
English: 5.2 Pharmacokinetic properties
Maltese: Proprjetajiet farmakodinamiċi
English: Oral solution One 60 ml bottle One 8 ml oral syringe One syringe adaptor.
Maltese: Soluzzjoni orali Flixkun wieħed ta' 60 ml Siringa tal-ħalq waħda ta' 8 ml Adapter wieħed tas-siringa Flixkun wieħed ta' 250 ml Siringa tal-ħalq waħda ta' 8 ml Adapter wieħed tas-siringa
English: Pseudo-obstruction
Maltese: Psewdo-imblokk
English: • anticholinergic medicines (see section above “Do not give Sialanar if the child or adolescent:”)
Maltese: • mediċini antikolinerġiċi (ara s-sezzjoni t'hawn fuq "Tagħtix Sialanar jekk it-tifel/tifla jew l adoloxxent:")
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.
Maltese: Minħabba li dan jaqbeż ir-rata ta' filtrazzjoni glomerulari u jidher li aktar minn 50% tad-doża hija eliminata mhux mibdula fl-awrina, huwa probabbli li leliminazzjoni mill-kliewi ta' glikopirronju jinvolvi kemm il-filtrazzjoni glomerulari kif ukoll issekrezzjoni tubulari fil-qrib mill-mekkaniżmu sekretorju tal-bażi.
English: Urinary retention is a known adverse reaction associated with anticholinergic medicinal products (15%).
Maltese: Iż-żamma tal-awrina hija reazzjoni avversa magħrufa assoċjata ma' prodotti mediċinali antikolinerġiċi (15%).
English: The assessment of reproductive endpoints for glycopyrronium is limited (see section 5.3).
Maltese: Il-valutazzjoni ta' punti ta' tmiem riproduttivi għal glikopirronju hija limitata (ara sezzjoni 5.3). Glikopirronju huwa kontraindikat waqt it-tqala (ara sezzjoni 4.3).
English: There is limited clinical trial evidence on the use of glycopyrronium in the adult population with pathological drooling.
Maltese: Hemm evidenza limitata tal-prova klinika dwar l-użu ta' glikopirronju fil-popolazzjoni adulta bi tlegħib patoloġiku.
English: Withdrawal effects are not expected when stopping Sialanar.
Maltese: Mhumiex mistennija effetti tal-irtirar meta jitwaqqaf Sialanar.
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.
Maltese: Glikopirronju huwa eliminat b'mod predominanti miċ-ċirkolazzjoni sistemika permezz ta' eliminazzjoni tal-kliewi u l-indeboliment talfwied mhuwiex maħsub li jirriżulta f'żieda klinikament relevanti fl-esponiment sistemiku ta' glikopirronju.
English: The single dose toxicity of glycopyrronium has been tested in a range of investigations, although only limited experimental details are available.
Maltese: It-tossiċità ta' doża unika ta' glikopirronju ġiet ittestjata f'firxa ta' investigazzjonijiet, għalkemm huma disponibbli biss dettalji esperimentali limitati.
English: single-dose.
Maltese: Ilma ppurifikat
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.
Maltese: Ilpopolazzjoni tal-analiżi primarja kienet riveduta sabiex tkopri biss pazjenti b'età ta' bejn 3 - 16-il sena li tat 19-il pazjent fil-grupp tas-soluzzjoni ta' glikopirrolat li tittieħed mill-ħalq u 17 fil-grupp talplaċebo.
English: Glycopyrronium is contraindicated in pregnancy (see section 4.3).
Maltese: L-użu waqt it-treddigħ huwa kontroindikat (ara sezzjoni 4.3).
English: Concomitant treatment with (see section 4.5);
Maltese: Kura konkomitanti ma' (ara sezzjoni 4.5).
English: Hepatic impairment
Maltese: Disturbi psikjatriċi Irritabilità
English: Data from sparse PK sampling in children suggests dose proportional PK.
Maltese: Id-data minn kampjunar ta' PK spars fit-tfal tissuġġerixxi PK proporzjonali għad-doża.
English: Glycopyrronium competitively inhibits cholinergic muscarinic receptors in salivary glands and other peripheral tissues, thus indirectly reducing the rate of salivation.
Maltese: Glikopirronju jinibixxi b'mod kompetittiv ir-riċetturi muskariniċi kolinerġiċi fil-glandoli tal-bżieq u tessuti periferali oħrajn, b'hekk titnaqqas ir-rata tal-bżieq b'mod indirett.
English: • antispasmodics used to treat sickness or vomiting e.g.domperidone and metaclopramide
Maltese: • antispażmodiċi użati għall-kura ta' dardir jew rimettar bħal domperidone u metoclopramide
English: Sialanar is not recommended in children aged <3 years in the symptomatic treatment of sialorrhoea (chronic pathological drooling) (see section 4.4).
Maltese: Popolazzjoni pedjatrika - tfal li għandhom <3 snin Sialanar mhuwiex rakkomandat fi tfal <3 snin fil-kura sintomatika ta' sijaloreja (tlegħib patoloġiku kroniku) (ara sezzjoni 4.4).
English: Thane Road
Maltese: Marine House
English: Baseline characteristics (age, weight, gender and race) do not affect the pharmacokinetics of glycopyrronium.
Maltese: Il-karatteristiċi tal-linja bażi (età, piż, sess u razza) ma jaffetwawx il-farmakokinetiċi ta' glikopirronju.
English: It is supplied in a 60 ml or 250 ml amber glass bottle in a cardboard carton.
Maltese: Din tiġi pprovduta fi flixkun tal-ħġieġ kulur l-ambra ta' 60 ml jew 250 ml f'kaxxa tal-kartun.
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.
Maltese: Suq (MAH) għandu jaqbel fuq il-kontenut u l-format tal-materjali edukattivi, inkluż il-mezzi ta'komunikazzjoni, il-modalitajiet ta' distribuzzjoni, u kull aspett ieħor tal-programm, mal-Awtorità Nazzjonali Kompetenti.
English: Primary efficacy endpoint was responder rate, defined as percentage showing ≥3-point improvement on the modified Teacher's Drooling Scale (mTDS).
Maltese: Il-punt ta' tmiem taleffikaċja primarju kien ir-rata ta' dawk li rrispondew, definita bħala perċentwal li juri titjib ta' ≥3-punti fuq il-Klassifika tat-Tlegħib ta' Teacher modifikata (modified Teacher's Drooling Scale - mTDS).
English: Skin and subcutaneous tissue disorders:
Maltese: Rilassanti tal-muskoli skeletriċi:
English: • Pneumonia (severe chest infection)
Maltese: • Pulmonite (infezzjoni severa fis-sider)
English: See section 6.6 for instructions for use.
Maltese: Għal istruzzjonijiet dwar l-użu, ara sezzjoni 6.6.
English: Potassium chloride solid oral dose: glycopyrronium may potentiate the risk of upper gastrointestinal injury associated with oral solid formulations of potassium chloride due to increased gastrointestinal transit time creating a high localized concentration of potassium ions.
Maltese: Doża solida li tittieħed mill-ħalq ta' klorur tal-potassju: glikopirronju jista' jsaħħaħ ir-riskju ta' korriment fl-apparat gastro-intestinali ta' fuq assoċjat ma' formulazzjonijiet solidi li jittieħdu mill-ħalq ta' klorur tal-potassju minħabba żieda fil-ħin ta' tranżitu gastrointestinali li joħloq konċentrazzjoni lokalizzata għolja ta' joni tal-potassju.
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.
Maltese: Il-materjali għandhom ikopru wkoll il-ħtieġa li tiġi evitata l-espożizzjoni għal temp sħun u sħana żejda; ir-riskju ta' taħsir tas-snien assoċjat ma' salivazzjoni mnaqqsa u l-bżonn ta' iġjene dentali regolari u kontrolli dentali u l-ħtieġa li jiġi ċċekkjat il-polz f'intervalli regolari.
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.
Maltese: Fil-firien b'dożi ogħla (15002000 mg/kg) ġew osservati tregħid, konvulżjonijiet kloniċi u toniċi u tbatija biex jittieħed in-nifs qabel il-mewt, u dan irriżulta minn insuffiċjenza respiratorja.
English: Although glycopyrronium has limited ability to cross the blood brain barrier, increased central nervous system effects have been reported in clinical trials (23%).
Maltese: Għalkemm glikopirronju għandu ħila limitata sabiex jaqsam il-barriera bejn id-demm u l-moħħ, ġiet irrapportata żieda fl-effetti tas-sistema nervuża ċentrali fil-provi kliniċi (23%).
English: Glycopyrronium should be used with caution in patients with acute myocardial infarction, hypertension, coronary artery disease, cardiac arrhythmias and conditions characterised by tachycardia (including thyrotoxicosis, cardiac insufficiency, cardiac surgery) due to the potential increase in heart rate, blood pressure and rhythm disorders produced by its administration.
Maltese: Glikopirronju għandu jintuża b'kawtela f'pazjenti b'infart mijokardijaku akut, pressjoni għolja, mard tal-arterja koronarja, taħbit irregolari tal-qalb u kundizzjonijiet ikkaratterizzati mit-takikardja (inkluż tirotossikożi, insuffiċjenza tal-qalb, kirurġija tal-qalb) minħabba ż-żieda potenzjali fir-rata ta' taħbit tal-qalb, pressjoni tad-demm u disturbi tar-ritmu prodotti mill-għoti tiegħu.
English: Based upon theoretical physicochemical considerations, the quaternary ammonium compound glycopyrronium would be expected to have low central bioavailability; no glycopyrronium was detectable in the CSF of anaesthetised surgical patients or patients undergoing caesarean section following a 6 - 8 µg/kg i.v.
Maltese: Abbażi ta' kunsiderazzjonijiet fiżikokimiċi teoretiċi, il-kompost tal-ammonju kwaternarju ta' glikopirronju għandu jkun mistenni li jkollu bijodisponibbiltà ċentrali baxxa; l-ebda glikopirronju ma kien osservat fis-CSF tal-pazjenti operati bil-loppju jew pazjenti li għaddejjin minn ċesarja wara doża ta' 6 - 8 µg/kg i.v. Fil-popolazzjoni pedjatrika 5 µg/kg i.v. ta' glikopirronju għandu bijdisponibbiltà ċentrali baxxa, ħlief fil-każ fejn il-barriera bejn id-demm u l-moħħ ġiet kompromessa (eż. infezzjoni tax-shunt).
English: Feeling sad
Maltese: Doża eċċessiva
English: Upper respiratory tract infection
Maltese: Infezzjonijiet u infestazzjonijiet Infezzjoni fin-naħa ta' fuq tal-apparat respiratorju
English: glycopyrronium.
Maltese: − Żomm dan il-fuljett.
English: • Allergic reaction (rash, itching, red raised itchy rash (hives), difficulty breathing or swallowing, dizziness) - frequency not known
Maltese: • Reazzjoni allerġika (raxx, ħakk, raxx aħmar imqabbeż bil-ħakk (ħorriqija), diffikultà biex tieħu nifs jew biex tibla', sturdament) - frekwenza mhux magħrufa
English: Other medicines and Sialanar
Maltese: Kif taħżen Sialanar
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:
Maltese: • li jipprovdi informazzjoni dwar il-ġestjoni u l-minimizzazzjoni tar-reazzjonijiet antikolinerġiċi, speċjalment dwar il-ġestjoni tal-istitikezza, iż-żamma tal-awrina, il-pulmonite, ir-riskju ta' sħana żejda, l-effetti fuq is-CNS jew doża eċċessiva; u dwar ir-reazzjonijiet allerġiċi.
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.
Maltese: L-analiżi tad-data farmakokinetika tal-popolazzjoni minn adulti f'saħħithom u tfal bi tlegħib kroniku moderat sa sever assoċjat mal-paraliżi ċerebrali li rċevew glikopirronju (mod ta' kif għandu jingħata u dożaġġi mhux speċifikati) ma wrewx il-farmakokinetiċi linerari tal-prodott mediċinali.
English: Overdose of glycopyrronium can result in anticholinergic syndrome, produced by the inhibition of cholinergic neurotransmission at muscarinic receptor sites.
Maltese: Doża eċċessiva ta' glikopirronju tista' tirriżulta fis-sindromu antikolinerġiku, prodott minn inibizzjoni ta' newrotrażmissjoni kolinerġika fis-siti tar-riċettur muskariniku.
English: 3 PHARMACEUTICAL FORM
Maltese: PROPRJETAJIET FARMAKOLOĠIĊI
English: Halitosis
Maltese: Pożoloġija
English: • digestive disorders (constipation; chronic heartburn and indigestion)
Maltese: • disturbi diġestivi (stitikezza, ħruq ta 'stonku kronika u indiġestjoni)
English: 0.71 points (SD: 2.14; 95% CI: -0.43-1.84)
Maltese: 2.14; 95% CI: -0.
English: Antimuscarinics are competitive inhibitors of the actions of acetylcholine at the muscarinic receptors of autonomic effector sites innervated by parasympathetic (cholinergic postganglionic) nerves.
Maltese: L-antimuskariniċi huma inibituri kompetittivi tal-azzjonijiet tal-aċetilkolina fir-riċetturi muskariniċi tas-siti tal-effettur awtonomiku innervati min-nervituri parasimpatiċi (postganglijoniċi kolinerġiċi).
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Maltese: Prodott mediċinali li jingћata b'riċetta ristretta tat-tabib (ara Anness I: Sommarju tal-Karatteristiċi talProdott, sezzjoni 4.2).
English: dose.
Maltese: Sentejn.
English: Each carton contains one bottle, one 8 ml oral syringe and one syringe adaptor.
Maltese: Kull kartuna fiha flixkun wieħed, siringa tal-ħalq waħda ta' 8 ml u adapter wieħed tas-siringa.
English: Gently pull down the plunger to the correct level (see Tables 1 and 2 for the correct dose).
Maltese: Bil-mod iġbed il-planġer sal-livell korrett (ara t-Tabelli 1 u 2 għad-doża korretta).
English: Symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and adolescents aged 3 years and older with chronic neurological disorders.
Maltese: Il-kura sintomatika ta' sijaloreja severa (tlegħib patoloġiku kroniku) fit-tfal u fl-adolexxenti li għandhom 3 snin u akbar b'disturbi newroloġiċi kroniċi.
English: • allergic reaction (rash, itching, red raised itchy rash (hives), difficulty breathing or swallowing, dizziness)
Maltese: • reazzjoni allerġika (raxx, ħakk, raxx aħmar imqabbeż bil-ħakk (ħorriqija), diffikultà biex tieħu nifs jew biex tibla ', sturdament)
English: • slow heart rate followed by rapid heart rate, palpitations and irregular heart beat
Maltese: • taħbit tal-qalb bil-mod segwit minn taħbit tal-qalb rapidu, palpitazzjonijiet u taħbit tal-qalb irregolari
English: Co-administration with food results in a marked decrease in systemic glycopyrronium exposure (see section 4.2.
Maltese: L-għoti flimkien mal-ikel jirriżulta fi tnaqqis evidenti fl-esponiment sistemiku tal-glikopirronju (ara sezzjoni 4.2).
English: Topiramate: glycopyrronium may potentiate the effects of oligohidrosis and hyperthermia associated with the use of topiramate, particularly in pediatric patients;
Maltese: Topiramate: glikopirronju jista' jsaħħaħ l-effetti ta' oligohidrosis u ipertermija assoċjati mal-użu ta' topiramate, b'mod partikolari f'pazjenti pedjatriċi;
English: − stomach ache and swelling (paralytic ileus)
Maltese: • Diffikultà biex tgħaddi l-ippurgar (stitikezza)
English: − has ulcerative colitis (inflammation of the intestine)
Maltese: − ikollu/ikollha kolite ulċerattiva (infjammazzjoni tal-musrana)
English: • raised pressure in the eye (which might cause glaucoma); photophobia (sensitivity to light);
Maltese: • pressjoni miżjuda fl-għajn (li tista' jikkawża glawkoma); fotofobija (sensittività għad-dawl); għajnejn xotti
English: fearfulness
Maltese: Ġestjoni
English: Most frequently reported treatment-emergent adverse events (glycopyrrolate vs placebo) were dry mouth, constipation, vomiting and nasal congestion.
Maltese: Laktar avvenimenti avversi li jirriżultaw mill-kura rrapportati b'mod frekwenti (glikopirrolat vs plaċebo) kienu ħalq xott, stitikezza, rimettar u konġestjoni fl-imnieħer.
English: − has myasthenia gravis (muscle weakness and tiredness)
Maltese: − ikollu/ikollha mijastenja gravi (dgħjufija fil-muskoli u għeja)
English: Dosing table for children and adolescents with normal renal function.
Maltese: Tabella tad-dożaġġ għat-tfal u għall-adolexxenti b'funzjoni normali tal-kliewi.
English: The bottle contains 60 ml or 250 ml of oral solution.
Maltese: Dan il-flixkun fih 60 ml jew 250 ml ta' taħlita likwida li tittieħed mill-ħalq.
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).
Maltese: Tista' wkoll tirrapporta effetti sekondarji direttament permezz tas-sistema ta' rappurtar nazzjonali imniżżla f'Appendiċi V.
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.
Maltese: • li jipprovdi informazzjoni dwar l-għoti ta' Sialanar, b'mod speċifiku dwar l-użu preċiż taddożaġġ preskritt, il-ħin tal-għoti qabel l-ikliet, l-evitar tal-għoti ta' Sialanar ma' ikliet b'ħafna xaħam, l-użu ta' siringa tal-ħalq u l-ħtieġa li timtela t-tabella tal-għoti fl-aħħar tal-kard ta' tfakkira (reminder card) għal min ikun qed jieħu ħsieb il-pazjent biex jiftakar id-doża korretta li għandha tingħata lit-tifel/tifla.
English: dose was low at approximately 3% (range 1.3-13.3%) in children aged 7-14 years undergoing intraocular surgery (n = 6) due to the medicinal product's low lipid solubility.
Maltese: Il-bijodisponibbiltà assoluta medja ta' glikopirronju li jittieħed mill-ħalq li tqabbel doża waħda li tittieħed mill-ħalq ta' 50 µg/kg u doża waħda ta' 5 µg/kg i.v. kienet baxxa f'bejn wieħed u ieħor 3% (firxa 1.3-13.3%) fi tfal li għandhom bejn 7-14-il sena li għaddejjin minn kirurġija intraokulari (n = 6) minħabba s-solubilità lipida baxxa tal-prodott mediċinali.
English: Within each system organ class, the adverse reactions are ranked by frequency, with the most frequent reactions first.
Maltese: F'kull sistema tal-klassifika tal-organi, ir-reazzjonijiet avversi huma kklassifikati permezz tal-frekwenza, bl-aktar reazzjonijiet frekwenti l-ewwel.