FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment of Enzootic Pneumonia caused by M. hyopneumoniae Dosage: 5.0 - 10.0 mg tiamulin hydrogen fumarate/kg bodyweight daily administered for 7 to 10 consecutive days.
Maltese: Trattament ta' Pnewmonja Enżootika kkawżata minn M. hyopneumoniae Dożaġġ: 5.0 - 10.
English: The clinical signs of acute toxicity in chickens are - vocalization, clonic cramps and lateral recumbency.
Maltese: Is-sintomi kliniċi ta' tossiċità akuta fit-tiġieġ huma - l-vokalizzazzjoni, bugħawwieġ kloniku u rqad fuq il-ġenb.
English: Warnings
Maltese: Awstrija
English: In turkeys serum levels of tiamulin are similar to chickens.
Maltese: Fid-dundjani l-livelli tas-serum ta' tiamulin huma simili għal dawk tat-tiġieġ.
English: • Rabbits
Maltese: • Ħnieżer
English: Prevention of Swine Dysentery caused by B. hyodysenteriae Dosage: 2.0 mg tiamulin hydrogen fumarate/kg bodyweight daily.
Maltese: Doża: 2.0 mg taimulin idroġen fumarat/kg piż tal-ġisem kuljum.
English: Prevention (at 2.0mg/kg bodyweight): Meat and offal: 1 day Treatment (at 5-10mg/kg bodyweight): Meat and offal: 6 days
Maltese: Prevenzjoni (b'2.0mg/kg bwt): 1 jum Trattament (b'5-10mg/kgbwt): 6 jiem
English: Conclusion: Having considered the grounds for referral and the responses provided by the Marketing Authorisation Holders, the CVMP concluded as follows:
Maltese: Wara li kkunsidra r-raġunijiet għar-referenza u t-tweġibiet ipprovduti mid-Detenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq, is-CVMP ikkonkluda kif ġej:
English: It appears to inhibit microbial protein production by producing biochemical inactive initiation complexes, which prevent elongation of the polypeptide chain.
Maltese: Jidher li jinibixxi l-produzzjoni tal-proteini mikrobjali billi jipproduċi kumplessi ta' inizjazzjoni mhux bijokimikament attivi, li ma jħallux il-katina talpolipeptidi titwal.
English: The dosage will normally be achieved by an inclusion level of 100 - 200 ppm tiamulin hydrogen fumarate in the finished feed providing that feed intake is unaffected.
Maltese: Id-doża normalment tinkiseb permezz ta' livell ta' inklużjoni ta' 100 - 200 ppm tiamulin hydrogen fumarate fl-għalf lest sakemm il-konsum tal-għalf ma jkunx ġie affettwat.
English: Severe growth depression, ataxia, paralysis or death may result.
Maltese: Jista' jkun hemm tnaqqis kbir fl-iżvilupp, atassja, paraliżi jew mewt.
English: The use of tiamutin premix and associated names in the treatment and prevention of infectious sinusitis and airsacculitis caused by M. gallisepticum, M. synoviae and M. meleagridis is agreed.
Maltese: Dundjani (dundjani żgħar (għat-tkabbir) u għat-tgħammir) Trattament u l-prevenzjoni ta' sinużite infettiva u sakkulite tal-arja kkawżati minn M. gallisepticum, M. synoviae u M. meleagridis.
English: Chickens Turkeys
Maltese: Fniek Majjali
English: 6.3 Shelf-life
Maltese: TAGĦRIF
English: Treatment and prevention of infectious sinusitis and airsacculitis caused by M. gallisepticum, M. synoviae and M. meleagridis.
Maltese: Trattament ta' Pnewmonja Enżootika kkawżata minn M. hyopneumoniae
English: Clinically relevant resistance to tiamulin requires combinations of mutations around the tiamulin binding site.
Maltese: Irreżistenza klinika rilevanti għal tiamulin teħtieġ il-kombinazzjonijiet ta' mutazzjonijiet madwar is-sit ta' rbit ta' tiamulin.
English: Preventive medication with tiamulin should be given for 2-4 weeks.
Maltese: Il-medikazzjoni preventiva b'tiamulin għandha tingħata għal 2-4 ġimgħat.
English: Austria
Maltese: Kundl AUSTRIA
English: p value p = 0.0011
Maltese: valuri p p = 0.0011
English: ATC Code: A03AB02.
Maltese: A03AB02.
English: Oral solution 60 ml
Maltese: Soluzzjoni orali 60 ml
English: 3.94 points (SD: 1.95; 95%; CI: 2.97-4.91)
Maltese: (SD: 1.95; 95%; CI: 2.97-4.91)
English: Haematology and chemistry
Maltese: Ematoloġija u kimika
English: Gastro-intestinal disorders
Maltese: Disturbi gastro-intestinali
English: • Irritability
Maltese: • Irritabilità
English: Dental
Maltese: Dentali
English: anticholinergics;
Maltese: antikolinerġiċi;
English: • antidepressants (tricyclic antidepressants)
Maltese: • antidipressanti (antidipressanti triċikliċi)
English: CNS adverse events
Maltese: Avvenimenti avversi tas-CNS
English: BCM Limited
Maltese: BCM Limited Thane Road
English: An AUC0-6 h of 8.64 µg.h/L was observed after 6 µg/kg i.v.
Maltese: AUX0-6 h ta' 8.64 µg.h/L kien osservat wara 6 µg/kg i.v. ta' glikopirronju.
English: The volume of distribution, 0.64 ± 0.29 L/kg in adults is similar to that of total body water.
Maltese: Il-volum ta' distribuzzjoni, 0.64 ± 0.29 L/kg fl-adulti huwa simili għal dak tal-total tal-ilma fil-ġisem.
English: Responder rate at week 8
Maltese: Rata ta' dawk li rrispondew f'ġimgħa 8
English: Nottinghamshire NG90 2PR UK
Maltese: Nottinghamshire NG90 2PR Ir-Renju Unit
English: • skeletal muscle relaxants (botulinum toxin)
Maltese: • rilassanti tal-muskoli skeletriċi (tossin tal-botulinum)
English: Citric acid (E330)
Maltese: Aċidu ċitriku (E330)
English: Raspberry flavouring (containing propylene glycol E1520) Sucralose (E955)
Maltese: Togħma ta' lampun (li fiha glikol tal-propilen E1520) Sucralose (E955)
English: • Fever (pyrexia)
Maltese: • Deni (piressija)
English: 1 refers to µg/kg glycopyrronium
Maltese: 1 jirreferi għal µg/kg glikopirronju
English: Open date: _________
Maltese: Data meta nfetaħ: _________
English: EU/1/16/1135/001 - 250 ml bottle EU/1/16/1135/002 - 60 ml bottle
Maltese: EU/1/16/1135/001 - 250 ml flixkun EU/1/16/1135/002 - 60 ml flixkun
English: Open date: ____________
Maltese: Data meta nfetaħ: ____________
English: Children and adolescents 3 years to less than 18 years:
Maltese: Tfal u adolexxenti minn 3 snin għal inqas minn 18-il sena:
English: Section 4 includes possible side effects related to the use of Sialanar.
Maltese: Sezzjoni 4 tinkludi effetti sekondarji possibbli relatati mal-użu ta' Sialanar.
English: Date of first authorisation: 15 September 2016
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 15 Settembru 2016
English: Frustration
Maltese: Frustrazzjoni
English: BCM Ltd Nottingham NG90 2PR United Kingdom
Maltese: Manifattur BCM Ltd Nottingham NG90 2PR Ir-Renju Unit
English: A small proportion (~5%) is eliminated in the bile.
Maltese: Proporzjon żgħir (~5%) huwa eliminat fil-bila.
English: (~12.8µg/kg) 1 (~25.6µg/kg) 1 (~38.4µg/kg) 1 (~51.2µg/kg) 1 (~64µg/kg) 1 ml ml ml ml ml
Maltese: 6µg/kg) 1 (~38.4µg/kg) 1 (~51.2µg/kg) 1 (~64µg/kg) 1 ml ml ml ml ml
English: Pharmacotherapeutic group: Medicinal products for functional gastrointestinal disorders, synthetic anticholinergics, quaternary ammonium compounds.
Maltese: Prodotti mediċinali għal disturbi gastrointestinali funzjonali, antikolinerġiċi sintetiċi, komposti tal-ammonju kwaternarju.
English: • Involuntary eye movement (nystagmus)
Maltese: • Moviment involontarju tal-għajnejn (nistagmus)
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.
Maltese: Is-sustanzi l-oħra huma benżoat tas-sodju (E211), ara sezzjoni 2 (Sialanar fih is-sodium u l-benzoate salt), togħma ta' lampun (li fih glikol tal-propilen E1520), sucralose (E955), aċidu ċitriku (E330) u ilma ppurifikat.
English: Mild to moderate sialorrhoea
Maltese: Sijaloreja ħafifa sa moderata
English: 14 of 19 patients (73.7%)
Maltese: 14 minn 19-il pazjent (73.7%) 3.94 punti
English: • Fungal infection (thrush) of the throat (oesophageal candidiasis)
Maltese: • Infezzjoni fungali (thrush) tal-gerżuma (kandidjażi fl-esofagu)
English: • inability to sweat normally
Maltese: • inabbiltà li tegħreq normali
English: Intraventicular shunt, brain tumour, encephalitis.
Maltese: Shunt intraventrikulari, tumur tal-moħħ, enċefalite.
English: Sialanar.
Maltese: Żamma tal-awrina.
English: Gastrointestinal motility disorder
Maltese: Disturb ta' motilità gastrointestinali
English: • neuroleptics/antipsychotics (clozapine, haloperidol, phenothiazine), used to treat some mental illnesses
Maltese: • newrolettiċi/antipsikotiċi (clozapine, haloperidol, phenothiazine), użati biex jikkuraw xi mard mentali
English: 2D barcode carrying the unique identifier included
Maltese: <barcode 2D li jkollu l-identifikatur uniku inkluż.>
English: Nystagmus
Maltese: Nistagmus
English: The active substance is glycopyrronium.
Maltese: Is-sustanza attiva hija glikopirronju.
English: For the full list of excipients, see section 6.1
Maltese: Għal-lista sħiħa ta' eċċipjenti, ara sezzjoni 6.1
English: 3 of 17 patients (17.6%)
Maltese: 3 minn 17-il pazjent (17.6%) 0.71 punti
English: Oesophageal candidiasis
Maltese: Kandidijażi esofagali
English: dose is relatively high at between 0.54 ± 0.14 L/h/kg and 1.14 ± 0.31 L/h/kg.
Maltese: L-eliminazzjoni totali tal-ġisem tal-prodott mediċinali wara doża i.v. hija relattivament għolja bejn 0.54 ± 0.14 L/h/kg u 1.14 ± 0.31 L/h/kg.
English: Antispasmodics: glycopyrronium may antagonize the pharmacologic effects of gastrointestinal prokinetic active substances such as domperidone and metoclopramide.
Maltese: Antispasmodiċi: glikopirronju jista' jantagonizza l-effetti farmakoloġiċi tas-sustanzi attivi prokinetiċi gastrointestinali bħal domperidone u metoclopramide.
English: Central Nervous System
Maltese: Sistema Nervuża Ċentrali
English: • Pneumonia (sever chest infection) - common
Maltese: • Pnewmonja (infezzjoni severa fis-sider) - komuni
English: Sodium benzoate (E211)
Maltese: Benżoat tas-sodju (E211)
English: Sialanar Oral Solution
Maltese: Sialanar Soluzzjoni Orali
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.
Maltese: L-għoti mill-ħalq kroniku ta' glikopirronju f'dożi ta' 4, 16 u 64 mg/kg sa massimu ta' 27 ġimgħa filklieb ipproduċa midrijasi, ċiklopleġija, kserostomija, emesi, dmugħ okkażjonali, injezzjoni tal-isklera u rinoreja.
English: Tricyclic antidepressants and MAOIs: may have additive anticholinergic effects.
Maltese: Antidepressanti triċikliċi u MAOIs: jista' jkollhom effetti antikolinerġiċi addittivi.
English: Clinical manifestations are caused by CNS effects, peripheral nervous system effects, or both.
Maltese: Il-manifestazzjonijiet kliniċi huma kkawżati minn effetti tas-CNS, effetti tas-sistema nervuża periferali, jew it-tnejn.
English: (~8.8µg/kg) 1 (~17.6µg/kg) 1 (~27.2µg/kg) 1 (~36µg/kg) 1 (~44.8µg/kg) 1 ml ml ml ml ml
Maltese: 2µg/kg) 1 (~36µg/kg) 1 (~44.8µg/kg) 1 ml ml ml ml ml
English: The adverse event profile was consistent with the one seen with anticholinergics (see section 4.4 and 4.8).
Maltese: Il-profil tal-avveniment avvers kien konsistenti ma' dak li deher bl-antikolinerġiċi (ara sezzjoni 4.4 u 4.8).
English: The effects of glycopyrronium on the reproductive system have not been investigated.
Maltese: L-effetti ta' glikopirronju fuq is-sistema riproduttiva ma ġewx investigati.
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).
Maltese: Barra minn hekk, 84% tat-tobba u 100% tal-ġenituri/dawk li jieħdu ħsieb it-tifel/tifla qiesu glikopirrolat bħala utli meta mqabbla ma' 41% u 56%, rispettivament, għall-plaċebo (p≤0.
English: History of intestinal obstruction, ulcerative colitis, paralytic ileus, pyloric stenosis and myasthenia gravis.
Maltese: Storja ta' mblokk tal-imsaren, kolite ulċerattiva, ileus paralitiku, stenożi piloriku u mijastenja gravis.
English: A decrease of >10% from the normal reference range at baseline for absolute neutrophil (11.2%) and red blood cell (11.1%) count, and increases >10% from the normal reference range at baseline for monocyte (16.7%) and absolute monocyte (11.2%) counts has been seen.
Maltese: Deher tnaqqis ta' >10% mill-medda ta' referenza normali fil-linja bażi għal għadd ta' newtrofili assolut (11.2%) u ċelluli ħomor tad-demm (11.1%), u dehru żidiet >10% mill-firxa ta' referenza normali fillinja bażi għal għadd ta' monoċiti (16.7%) u għadd assolut ta' monoċiti (11.2%).
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.
Maltese: Il-prodotti mediċinali b'karatteristiċi antikolinerġiċi (eż. antistamini, antidipressanti) jistgħu jikkawżaw effetti parasimpatolitiċi kumulattivi inkluż ħalq xott, żamma tal-awrina, stitikezza u konfużjoni, u żieda fir-riskju tas-sindromu ta' intossikazzjoni antikolinerġika.
English: EU/1/16/1135/001 (250 ml bottle) EU/1/16/1135/002 (60 ml bottle)
Maltese: EU/1/16/1135/002 (60 ml flixkun)
English: Tabulated summary of adverse reactions
Maltese: Sommarju tabulat tar-reazzjonijiet avversi
English: • Upper respiratory tract infection (chest infection);
Maltese: • Infezzjoni fl-apparat respiratorju ta' fuq (infezzjoni fis-sider);
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).
Maltese: Fi studju fl-adulti f'saħħithom, doża waħda ta' bromur ta'glikopirronju ta' 2000 µg irriżultat f'AUC ta' 2.39 µg.h/L (imsajma).
English: Pack size of one bottle, one 8 ml low density polyethylene oral syringe (0.1 ml graduations) and one syringe adaptor.
Maltese: Daqs tal-pakkett ta' flixkun wieħed, siringa tal-ħalq waħda ta' polietilen ta' densità baxxa ta' 8 ml (gradwazzjonijiet ta' 0.1 ml) u adapter wieħed tas-siringa.
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).
Maltese: Ir-reazzjonijiet avversi rrapportati fir-riċensjoni għall-provi li jużaw glikopirronju għas-sijaloreja filpopolazzjoni pedjatrika (inkluż 2 provi kkontrollati mill-plaċebo, studju dwar is-sigurtà mhux ikkontrollat bl-użu ta' glikopirronju għal perjodu ta' 6 xhur, u 3 studji ta' appoġġ b'data tal-avveniment avvers fil-popolazzjoni fil-mira) huma elenkati fis-sistema tal-klassifika tal-organi MedDRA (Tabella 3).
English: Mild to moderate renal impairment (eGFR <90 - ≥30 ml/min/1.73m2) doses should be reduced by 30% (see Table 2).
Maltese: Id-dożi tal-indeboliment ħafif sa moderat tal-kliewi (eGFR <90 - ≥30 ml/min/1.73m2) għandhom jitnaqqsu bi 30% (ara Tabella 2).
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).
Maltese: Tmienja u tletin pazjent li għandhom bejn 3-23 sena li jiżnu mill-anqas 27 lb (12.2 kg) bi tlegħib sever (il-ħwejjeġ niedja 5-7 ijiem/ġimgħa) intgħażlu b'mod każwali għall-kura bi glikopirronju għal tmien ġimgħat (n = 20), 20-100 μg/kg (ma jaqbżux 3 mg b'kollox) tliet darbiet kuljum, jew plaċebo li jaqbel (n = 18).
English: A mean increase in total systemic exposure (AUClast) of up to 1.4 fold was seen in adult subjects with mild and moderate renal impairment (GFR ≥30mL/min/1.73m2) and up to 2.2 fold in subjects with severe renal impairment or end stage renal disease (estimated GFR <30 mL/min/1.73m2).
Maltese: Żieda medja fl-esponiment sistemiku totali (AUClast) sa 1.4 drabi aktar deher f'individi adulti b'indeboliment ħafif u moderat tal-kliewi (GFR ≥30mL/min/1.73m2) u sa 2.2 drabi aktar f'individwi b'indeboliment sever tal-kliewi jew marda tal-kliewi tal-aħħar stadju (GFR stmat ta' <30 mL/min/1.73m2).
English: ANNEX II
Maltese: Dublin 2
English: Upon oral administration, high LD50 values of 550 mg/kg in mice and above 1,000 mg/kg in rats were reported.
Maltese: Mal-għoti mill-ħalq, ġew irrappurtati valuri LD50 għoljin ta' 550 mg/kg fil-ġrieden u ta' aktar minn 1,000 mg/kg fil-firien.
English: • Abnormal contractions of the digestive tract when food is ingested (gastrointestinal motility disorder)
Maltese: • Kontrazzjonijiet anormali tal-passaġġ diġestiv meta l-ikel jiġi inġestit (disturb ta' motilità gastrointestinali)
English: Following administration of 3H-labelled glycopyrronium more than 90% of the radiolabel disappeared from the plasma in 5 minutes, and almost 100% within 30 minutes, reflecting rapid distribution.
Maltese: Wara l-għoti ta' glikopirronju 3H-tikkettjat aktar minn 90% tad-doża radjutikketata sparixxiet mill-plażma f'5 minuti, u kważi 100% fi 30 minuta, li tirrifletti distribuzzjoni mgħaġġla.
English: Increased central nervous system effects have been reported in clinical trials including: irritability; drowsiness; restlessness; overactivity; short attention span; frustration; mood changes; temper outbursts or explosive behaviour; excessive sensitivity; seriousness or sadness; frequent crying episodes; fearfulness.
Maltese: Żieda fl-effetti tas-sistema nervuża ċentrali ġew irrapportati fi provi kliniċi li jinkludu: irritabbiltà; ngħas; irrikwetezza f'ġismek; attività żejda; kapaċità ta' żamma ta' attenzjoni qasira; frustrazzjoni; bidliet fil-burdata; żbroffi ta' tempra jew imġiba splussiva; sensittività eċċessiva; serjetà jew dwejjaq, episodji frekwenti ta' biki; biża'.
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.
Maltese: Bidliet modesti fil-volum ta' distribuzzjoni (Vss) u tneħħija (Cl) kienu osservati fi tfal li għandhom bejn sena u 3 snin, li jwassal għal nofs ħajja ta' eliminazzjoni statistikament iqsar b'mod sinifikanti (t½, z) milli dak osservat fi gruppi iżgħar (<l-età ta' sena; p = 0.037) jew akbar (>l-età ta' 3 snin; p = 0.
English: Pneumonia is a known adverse reaction associated with anticholinergic medicinal products (7.9%).
Maltese: Il-pulmonite hija reazzjoni avversa magħrufa assoċjata ma' prodotti mediċinali antikolinerġiċi (7.9%).
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..
Maltese: Fil-viżta tal-ħruġ ta' ġimgħa 24, 52.3% (95% intervall ta' kunfidenza 43.7-60.9) tal-pazjenti (n=130) kellhom mill-anqas tnaqqis ta' tliet punti fl-mTDS mil-linja bażi u kienu kklassifikati bħala dawk li rrispondew għall-kura b'soluzzjoni ta' glikopirrolat li tittieħed mill-ħalq.
English: Each ml contains 2.3 mg sodium benzoate (E211).
Maltese: Kull ml fih 2.3 mg ta' sodium benzoate (E211).
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.
Maltese: 1%), bikarbonat (13.3%), u krejatinina (10.
English: The PK of glycopyrronium has been shown to be essentially independent of age in children in the age range 0.19 - 14 years administered a 5 µg/kg i.v.
Maltese: Il-PK ta' glikopirronju intwera li huwa essenzjalment indipendenti mill-età ta' tfal fil-firxa tal-etajiet ta' 0.19 - 14-il sena mogħtija doża waħda ta' 5 µg/kg i.v.
English: There are limited data available relating to interactions with other medicinal products in the paediatric age group.
Maltese: Hemm data limitata disponibbli fir-rigward tal-interazzjonijiet ma' prodotti mediċinali oħrajn fil-grupp tal-età pedjtarika.
English: Sialanar 320 micrograms/ml oral solution Glycopyrronium
Maltese: Sialanar 320 mikrogramma/ml soluzzjoni li tittieħed mill-ħalq
English: Contains sodium benzoate (E211).
Maltese: Fih is-sodium benzoate (E211).
English: • Reduced secretions in the chest;
Maltese: • Sekrezzjonijiet imnaqqsa fis-sider;
English: Physostigmine salicylate is recommended when tachydysrhythmia with subsequent hemodynamic compromise, intractable seizure, severe agitation or psychosis is present.
Maltese: Physostigmine salicylate huwa rrakkomandat meta t-tachydysrhythmia b'kompromess emodinamiku sussegwenti, aċċessjoni intrattabbli, aġitazzjoni severa jew psikożi huma preżenti.
English: A reduction in corpora lutea was observed in female rats administered glycopyrronium.
Maltese: Ġie osservat tnaqqis fil-corpora lutea fil-firien femminili li ngħataw glikopirronju.
English: Volume of distribution is somewhat higher in the paediatric population(s), in the range 1.31 to 1.83 L/kg.
Maltese: Il-volum tad-distribuzzjoni huwa kemxejn ogħla fil-popolazzjoni(jiet) pedjatriċi, fil-firxa ta' 1.31 sa 1.83 L/kg.
English: Peripheral antimuscarinic effects that are produced as the dose increases are: decreased production of secretions from the salivary, bronchial and sweat glands; dilatation of the pupils (mydriasis) and paralysis of accommodation (cyclopegia); increased heart rate; inhibition of micturition and reduction in gastrointestinal tone; inhibition of gastric acid secretion.
Maltese: L-effetti antimuskariniċi periferali li huma prodotti hekk kif id-doża tiżdied huma: tnaqqis filproduzzjoni ta' sekrezzjonijiet mill-glandoli tal-bżieq, tal-bronki u tal-għaraq; twessigħ tal-ħabba talgħajn (midrijasi) u paraliżi tal-akkomodazzjoni (ċiklopeġija); żieda fir-rata ta' taħbit tal-qalb; inibizzjoni sabiex tgħaddi l-awrina u tnaqqis fit-ton gastrointestinali; inibizzjoni tas-sekrezzjoni talaċidu gastriku.
English: Avoid exposing the child to hot or very warm temperature (hot weather, high room temperature) to avoid over heating and the possibility of heat stroke.
Maltese: Evita li tesponi t-tifel/tifla għal temperatura tikwi jew sħuna ħafna (temp sħun. temperatura tal-kamra għolja) biex tiġi evitata s-sħana żejda u l-possibilità ta' kolp tas-sħana.
English: Glycopyrronium
Maltese: Glikopirronju
English: Neuroleptics/antipsychotics: the effects of active substances such as phenothiazines, clozapine and haloperidol may be potentiated.
Maltese: Newroleptiċi/antipsikotiċi: l-effetti ta' sustanzi attivi bħal phenothiazines, clozapine u haloperidol jistgħu jissaħħu.
English: Glycopyrronium is a quaternary ammonium antimuscarinic with peripheral effects similar to those of atropine.
Maltese: Glikopirronju huwa antimuskariniku tal-ammonju kwaternarju b'effetti periferali simili għal dawk ta' atropine.
English: • restlessness; overactivity; short attention span; frustration; mood changes; temper outbursts or explosive behaviour; excessive sensitivity; seriousness or sadness; frequent crying episodes;
Maltese: • irrekwitezza; attività eċċessiva; tiffoka l-attenzjoni għal żmien qasir; frustrazzjoni; bidliet filburdata; splużjonijiet tat-tempra jew imġiba splussiva; sensittività eċċessiva; serjetà jew dwejjaq; episodji ta' biki frekwenti; biża'
English: • inflammation and swelling of sinuses (sinusitis)
Maltese: • infjammazzjoni u neħfa tas-sinuses (sinożite)
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.
Maltese: Il-profil tas-sigurtà huwa kkaratterizzat aktar minn sintomi oħrajn, relatati mal-effetti antikolinerġiċi b'rata ta' ≥15%, inkluż żamma tal-awrina, fwawar u konġestjoni fl-imnieħer.
English: • Nose bleeds (epistaxis)
Maltese: • Tinfaraġ (epistassi)
English: Each ml contains 400 micrograms glycopyrronium bromide equivalent to 320 micrograms of glycopyrronium.
Maltese: U KWANTITATTIVA Kull ml fih 400 mikrogramma ta' bromur tal-glikopirronju ekwivalenti għal 320 mikrogramma ta' glikopirronju.