FrancophonIA/ELRC3.0 huggingface dataset:
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu
English: • dry mouth
Maltese: • tħossok stordut
English: Hold your breath as long as you comfortably can, up to 10 seconds (See Figure 11).
Maltese: Żomm in-nifs kemm tista' mingħajr ma tbati, sa 10 sekondi (Ara Figura 11).
English: SGRQ total score
Maltese: Punteġġ totali talSGRQ
English: An overdose of Bevespi Aerosphere may lead to exaggerated anticholinergic and/or β2-adrenergic signs and symptoms, the most frequent of which include blurred vision, dry mouth, nausea, muscle spasm, tremor, headache, palpitations and systolic hypertension.
Maltese: Aerosphere tista' twassal għal sinjali u sintomi ta' antikolinerġiċi u/jew adrenerġiċi β2 esaġerati, li l-aktar frekwenti minnhom huma vista mċajpra, ħalq xott, nawsja, spażmi fil-muskoli, rogħda, uġigħ ta' ras, palpitazzjonijiet u pressjoni sistolika għolja.
English: There were improvements compared to formoterol in PINNACLE 1 and PINNACLE 2.
Maltese: Kien hemm titjib meta mqabbel ma' formoterol f'PINNACLE 1 u PINNACLE 2.
English: Both central and peripheral deposition were observed.
Maltese: Ġew osservati kemm depożitu ċentrali kif ukoll periferali.
English: FOIL POUCH
Maltese: Franza jew
English: • When the arrow reaches ‘0', you must stop using your inhaler.
Maltese: • Meta l-vleġġa tilħaq “0”, għandek tieqaf tuża l-inalatur tiegħek.
English: The clinical development program for Bevespi Aerosphere included three 24-week, randomised, double-blind, placebo-controlled, parallel-group pivotal Phase III studies in 5,433 patients with moderate to very severe COPD (PINNACLE 1, PINNACLE 2 and PINNACLE 4).
Maltese: Il-programm ta' żvilupp kliniku għal Bevespi Aerosphere inkluda tliet studji ta' 24 ġimgħa, randmomised, double-blind, ikkontrollati bi plaċebo, ta' grupp parallel, pivotali , ta' Fażi
English: In PINNACLE 1 and PINNACLE 2, Bevespi Aerosphere provided improvements in breathlessness as demonstrated by Self-administered Computerised Transitional Dyspnoea Index (SAC TDI) focal score over 24 weeks compared to placebo and glycopyrronium (see Table 2).
Maltese: Aerosphere pprovda titjib fil-qtugħ ta' nifs kif wera lpunteġġ fokali tal-Indiċi ta' Dispneja Temporanju Kompjuterizzat Mogħti mill-Pazjent Stess (SAC TDI) fuq perjodu ta' 24 ġimgħa meta mqabbel ma' plaċebo u glycopyrronium (ara t-Tabella 2).
English: Bevespi Aerosphere should be administered with caution to patients being treated with medicinal products known to prolong the QTc interval (see section 4.4).
Maltese: Aerosphere għandu jingħata b'kawtela lil pazjenti li qegħdin jiġu ttratti bi prodotti mediċinali li huma magħrufa li jtawlu l-intervall QTc (ara sezzjoni 4.4).
English: For pharmacokinetic purposes each component can therefore be considered separately.
Maltese: Għaldaqstant, għall-finijiet farmakokinetiċi, kull komponent jista' jiġi kkunsidrat b'mod separat.
English: Following inhalation of the glycopyrronium and formoterol combination, the pharmacokinetics of each component was similar to those observed when each active substance was administered separately.
Maltese: Wara t-teħid man-nifs tal-kombinazzjoni ta' glycopyrronium u formoterol, il-farmakokinetika ta' kull komponent kienet simili għal dik osservata meta s-sustanza attiva ngħatat b'mod separat.
English: A lung deposition study with Bevespi Aerosphere conducted in healthy volunteers demonstrated that on average 38% of the nominal dose is deposited into the lung.
Maltese: Studju dwar id-depożitu fil-pulmun b'Bevespi Aerosphere mwettaq f'voluntiera b'saħħithom wera li bħala medja 38 % tad-doża nominali hija ddepożitata fil-pulmun.
English: β-adrenergic blockers β-adrenergic blockers (including eye drops) can weaken or inhibit the effect of β2-adrenergic agonists, such as formoterol.
Maltese: L-imblokkaturi adrenerġiċi β (inkluż qtar għall-għajnejn) jistgħu jdgħajfu jew jinibixxu l-effett talagonisti adrenerġiċi-β2, bħal formoterol.
English: Daily rescue Ventolin (inhalations/day)
Maltese: Ventolin ta' salvataġġ ta' kuljum (inalazzjonijiet/jum)
English: Gastrointestinal disorders Dry mouth 2, Nausea
Maltese: F'pazjenti b'indeboliment tal-fwied sever, Bevespi
English: Improvements compared to formoterol were observed in PINNACLE 2 (see Table 2).
Maltese: Titjib meta mqabbel ma' formoterol ġie osservat f'PINNACLE 2 (ara t-Tabella 2).
English: A placebo- and active-controlled (moxifloxacin) thorough QT study in 69 healthy subjects did not demonstrate a clinically relevant effect on the QT interval, using a threshold of 10 ms.
Maltese: Studju QT iddettaljat, ikkontrollat bi plaċebo u kkontrollat b'mod attiv (moxifloxacin) f'69 individwu b'saħħithom ma weriex effett klinikament rilevanti fuq l-intervall QT, permezz ta' livell limitu ta' 10 ms.
English: Glycopyrronium did not cause any adverse effects on fertility in rats.
Maltese: Glycopyrronium ma kkawżax xi effetti avversi fuq ilferilità fil-firien.
English: Bevespi Aerosphere 7.2 mcg/5 mcg pressurised inhalation glycopyrronium/formoterol fumarate dihydrate Inhalation use
Maltese: Aerosphere 7.2 mcg/5 mcg sustanza taħt pressjoni għolja li tittieħed man-nifs glycopyrronium/formoterol fumarate dihydrate Użu b'teħid bin-nifs
English: Bevespi Aerosphere 7.2 micrograms/5 micrograms pressurised inhalation, suspension glycopyrronium/formoterol fumarate dihydrate
Maltese: Aerosphere 7.2 mikrogrammi/5 mikrogrammi sustanza taħt pressjoni għolja li tittieħed mannifs, suspensjoni glycopyrronium/formoterol fumarate dihydrate
English: In PINNACLE 1, PINNACLE 2 and PINNACLE 4, Bevespi Aerosphere provided an improvement in disease-specific health-related quality of life, as indicated by a reduction in the St George's Respiratory Questionnaire (SGRQ) total score over 24 weeks compared to placebo and glycopyrronium [see Table 2].
Maltese: Aerosphere pprovda titjib fil-kwalità talħajja b'rabta mas-saħħa speċifika għall-marda, kif indikat minn tnaqqis fil-punteġġ totali talKwestjonarju Respiratorju ta' San Ġorġ (SGRQ) fuq perjodu ta' 24 ġimgħa meta mqabbel ma' plaċebo u glycopyrronium [ara t-Tabella 2].
English: Based on literature, and an in-vitro human hepatocyte study, metabolism plays a minor role in the overall elimination of glycopyrronium.
Maltese: Abbażi tal-letteratura, u studju in vitro taċ-ċellula epatika tal-bniedem, il-metaboliżmu għandu rwol minuri fl-eliminazzjoni globali ta' glycopyrronium.
English: Non-clinical data reveal no specific hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Maltese: Tagħrif mhux kliniku bbażat fuq studji konvenzjonali ta' sigurtà farmakoloġika, tossiċità minn dożi ripetuti, ġenotossiċità u potenzjal karċinoġenu ma juri l-ebda periklu speċifiku għallbnedmin.
English: There is no relevant use of Bevespi Aerosphere in children and adolescents (under 18 years of age) for the indication of COPD.
Maltese: M'hemm l-ebda użu rilevanti ta' Bevespi Aerosphere fi tfal u adolexxenti (li għandhom inqas minn 18-il sena) għall-indikazzjoni ta' COPD.
English: Bevespi Aerosphere 7.2 micrograms / 5 micrograms pressurised inhalation, suspension glycopyrronium / formoterol fumarate dihydrate
Maltese: Aerosphere 7.2 mikrogrammi/5 mikrogrammi sustanza taħt pressjoni għolja li tittieħed man-nifs, suspensjoni glycopyrronium / formoterol fumarate dihydrate
English: The active substances are glycopyrronium and formoterol fumarate dihydrate.
Maltese: Aerosphere fih żewġ sustanzi attivi msejħa glycopyrronium u formoterol fumarate dihydrate.
English: The terminal elimination half-life of glycopyrronium following oral inhalation derived via population pharmacokinetics analysis was 15 hours.
Maltese: Ilhalf-life ta' eliminazzjoni terminali ta' glycopyrronium wara teħid man-nifs mill-ħalq derivata permezz tal-analiżi farmakokinetika tal-popolazzjoni kienet ta' 15-il siegħa.
English: • high blood sugar levels
Maltese: GĦAMLA KWALITATTIVA
English: Step 5: While breathing in deeply and slowly, press down on the centre of the dose indicator until the pressurised container stops moving in the actuator and a puff of medicine has been released (See Figure 10).
Maltese: Filwaqt li tieħu nifs fil-fond u bil-mod 'il ġewwa, agħfas 'l isfel fuq iċ-ċentru tal-indikatur taddoża sakemm il-kontenitur taħt pressjoni ma jibqax jiċċaqlaq fl-azzjonatur u tiġi rilaxxata nefħa tal-mediċina (Ara Figura 10).
English: number in Intent to Treat population primary endpoint in all studies PINNACLE 1 and PINNACLE 2 used SAC-TDI.
Maltese: numru fil-popolazzjoni b'Intenzjoni li Tiġi Ttratta punt aħħari primarju fl-istudji kollha PINNACLE 1 u PINNACLE 2 użaw SAC-TDI. PINNACLE 4 uża
English: Clinical drug-drug interaction studies have not been conducted with Bevespi Aerosphere, however, the potential for metabolic interactions is considered to be low based on in-vitro studies (see section 5.2).
Maltese: Aerosphere, madankollu, il-potenzjal għal interazzjonijiet metaboliċi huwa kkunsidrat baxx fi studji in vitro (ara sezzjoni 5.2).
English: On actuation of Bevespi Aerosphere, a volume of the suspension is expelled from the pressurised container at high velocity.
Maltese: Aerosphere, volum mis-suspensjoni jiġi rrilaxxat 'il barra mill-kontenitur taħt pressjoni b'veloċità għolja.
English: Bevespi Aerosphere 7.2 micrograms/5 micrograms pressurised inhalation, suspension
Maltese: Aerosphere 7.2 mikrogrammi/5 mikrogrammi sustanza taħt pressjoni għolja li tittieħed mannifs, suspensjoni
English: Figure 14 Step 1: Take the pressurised container out of the actuator (See Figure 15).
Maltese: Pass 1: Neħħi l-kontenitur taħt pressjoni mill-azzjonatur (Ara Figura 15).
English: Each single actuation contains glycopyrronium bromide equivalent to 7.2 micrograms of glycopyrronium, and 5 micrograms of formoterol fumarate dihydrate.
Maltese: Kull attwazzjoni unika fiha glycopyrronium bromide ekwivalenti għal 7.2 mikrogrammi ta' glycopyrronium, u 5 mikrogrammi ta' formoterol fumarate dihydrate.
English: Each single puff delivers a dose of 9 micrograms glycopyrronium bromide (equivalent to 7.2 micrograms of glycopyrronium), and 5 micrograms of formoterol fumarate dihydrate.
Maltese: Kull nefħa tagħti doża ta' 9 mikrogrammi ta' glycopyrronium bromide (ekwivalenti għal 7.2 mikrogrammi ta' glycopyrronium) u 5 mikrogrammi ta' formoterol fumarate dihydrate.
English: • medicines that lower potassium in your blood.
Maltese: • mediċini li jbaxxu il-potassju fid-demm tiegħek.
English: The tabulated list of adverse reactions is based on the experience with Bevespi Aerosphere in clinical trials and experience with the individual components.
Maltese: Il-lista f'tabella tar-reazzjonijiet avversi hija bbażata fuq l-esperjenza b'Bevespi Aerosphere fi provi kliniċi u l-esperjenza bil-komponenti individwali.
English: As a consequence of the differential density of muscarinic receptors and β2-adrenoceptors in the central and peripheral airways of the lung, muscarinic antagonists are more effective in relaxing central airways, and β2-adrenergic agonists are more effective in relaxing peripheral airways; relaxation of both central and peripheral airways with combination treatment may contribute to its beneficial effects on lung function.
Maltese: Bħala konsegwenza fid-differenza tad-densità tar-riċetturi muskariniċi u l-adrenoriċetturi β2 filpassaġġi tal-arja ċentrali u periferali tal-pulmun, l-antagonisti muskariniċi huma aktar effikaċi biex jirrilassaw il-passaġġi tal-arja ċentrali u l-agonisti adrenerġiċi β2 huma effikaċi biex jirrilissaw ilpassaġġi tal-arja periferali; rilassament kemm tal-passaġġi tal-arja ċentrali kif ukoll dawk periferali b'trattament ta' kombinazzjoni tista' tikkontribwixxi għall-effetti ta' benefiċċju tiegħu fuq il-funzjoni tal-pulmun.
English: Hypokalaemia β2-adrenergic agonists may produce significant hypokalaemia, which may increase the susceptibility to cardiac arrhythmias.
Maltese: Agonisti adrenerġiċi β2 jistgħu jipproduċu ipokalimja sinifikanti, li tista' żżid is-suxxettibbiltà għal aritmiji kardijaċi.
English: Mouthpiece
Maltese: Ipokalimja
English: The other ingredients are norflurane, 1,2- distearoyl-sn-glycero-3-phosphocholine and calcium chloride.
Maltese: Norflurane, 1,2-distearoyl-sn-glycero-3-phosphocholine ucalcium chloride.
English: Studies in rats have shown adverse effects on fertility only at dose levels higher than the maximum human exposure to formoterol (see section 5.3).
Maltese: Studji f'firien urew effetti avversi fuq il-fertilità biss f'livelli ta' doża ogħla mill-esponiment massimu tal-bniedem għal formoterol (ara sezzjoni 5.3).
English: The inhaler is a pressurised metered dose inhaler, comprising an aluminium pressurised container with an attached dose indicator, supplied with a white plastic actuator body and mouthpiece with an orange dust cap. Each inhaler is individually packaged in a foil laminate pouch containing a desiccant sachet and packed into a carton.
Maltese: L-inalatur huwa inalatur tad-doża mkejjel taħt pressjoni għolja, li jinkludi kontenitur taħt pressjoni talaluminju b'indikatur tad-doża mwaħħal miegħu, fornit ma' qafas ta' azzjonatur tal-plastik abjad u biċċa tal-ħalq b'għatu oranġjo li jilqa' mit-trab.
English: Immediate breathing difficulties If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using Bevespi Aerosphere: Stop using this medicine and seek medical help immediately, as you may have a serious condition called paradoxical bronchospasm.
Maltese: Waqqaf l-użu ta' din il-mediċina u fittex parir mediku immedjatament, peress li jista' jkollok kondizzjoni serja msejħa bronkospażmu paradossali.
English: The pharmacokinetics of formoterol was best described by a two compartment disposition model with a first-order rate constant of absorption and linear elimination.The typical clearance (CL/F) of formoterol was 99 L/h.
Maltese: Il-farmakokinetika ta' formoterol kienet deskritta bl-aħjar mod minn mudell ta' dispożizzjoni b'żewġ kompartimenti b'rata ta' assorbiment tal-ewwel ordni kostanti u eliminazzjoni lineari.
English: Pharmacotherapeutic group: Drugs for obstructive airway diseases: adrenergics in combination with anticholinergics, ATC code: R03AL07.
Maltese: Mediċini għal mard ostruttiv tal-passaġġi tal-arja: adrenerġiċi f'kombinazzjoni ma' antikolinerġiċi, Kodiċi ATC:
English: • agitation
Maltese: • aġitazzjoni
English: Hyperglycaemia
Maltese: Wedel Il-Ġermanja
English: AstraZeneca Pharma Poland Sp. z o.o.
Maltese: Ma twettaq l-ebda studju farmakokinetiku b'Bevespi
English: Chest pain
Maltese: Jekk tuża Bevespi
English: • you have an eye problem called narrow-angle glaucoma (also called angle-closure glaucoma)
Maltese: • diffikultà biex tgħaddi l-awrina (żamma tal-awrina)
English: • muscle cramps
Maltese: • diffikultà biex torqod
English: The pharmacokinetics of glycopyrronium was best described by a two-compartment disposition model with first-order absorption and linear elimination.
Maltese: Il-farmakokinetika ta' glycopyrronium kienet deskritta bl-aħjar mod minn mudell ta' dispożizzjoni b'żewġ kompartimenti b'assorbiment tal-ewwel ordni u eliminazzjoni lineari.
English: Bevespi Aerosphere is for inhalation use.
Maltese: Aerosphere ma' kwalunkwe mediċina oħra.
English: Steady state is achieved within 2-3 days of repeated dosing of Bevespi Aerosphere, and the extent of exposure is approximately 2.3 times and 1.5 times higher than after the first dose, for glycopyrronium and formoterol, respectively.
Maltese: Aerosphere, u l-estent tal-esponiment huwa madwar 2.3 darbiet u 1.5 darbiet aktar wara l-ewwel doża, għal glycopyrronium u formoterol, rispettivament.
English: Agitation Restlessness Insomnia
Maltese: Diffikultajiet fit-teħid tan-nifs immedjati
English: PINNACLE 4 used TDI.
Maltese: F'PINNACLE 4, Bevespi
English: Package leaflet: Information for the user
Maltese: Sorsi oħra ta᾽ informazzjoni
English: CYP2D6 and CYP2C have been identified as being primarily responsible for Odemethylation.
Maltese: Mogħdijiet metaboliċi sekondarji jinkludu deformilazzjoni u konjugazzjoni tas-sulfat. CYP2D6 u CYP2C ġew identifikati bħala li huma prinċipalment responsabbli għal demetilizzazzjoni-O.
English: These are known pharmacological manifestations seen after administration of high doses of adrenoceptor agonists.
Maltese: Dawn huma manifestazzjonijiet farmakoloġiċi magħrufa li huma osservati wara l-għoti ta' dożi għoljin ta' agonisti adrenoċetturi.
English: In patients with severe COPD, hypokalaemia may be potentiated by hypoxia and concomitant treatment (see section 4.5).
Maltese: F'pazjenti b'COPD severa, ipokalimja tista' titqawwa b'ipoksja u b'trattament konkomitanti (ara sezzjoni 4.5).
English: Step 2: Shake the inhaler well before each use (See Figure 7).
Maltese: Pass 2: Ħawwad l-inalatur sew qabel kull użu (Ara Figura 7).
English: • Bevespi Aerosphere comes with a dose indicator on the top of the pressurised container (See Figure 1).
Maltese: Aerosphere jiġi b'indikatur tad-doża fil-parti ta' fuq tal-kontenitur taħt pressjoni (Ara Figura 1).
English: In PINNACLE 4, Bevespi Aerosphere provided improvements in breathlessness as demonstrated by TDI focal score over 24 weeks compared to placebo and glycopyrronium (see Table 2).
Maltese: Aerosphere pprovda titjib fil-qtugħ tan-nifs kif muri minn punteġġ fokali TDI fuq perjodu ta' 24 ġimgħa meta mqabbel ma' plaċebo u glycopyrronium (ara t-Tabella 2).
English: Concomitant treatment with methylxanthine derivatives, steroids, or non-potassium-sparing diuretics may potentiate the possible initial hypokalaemic effect of β2-adrenergic agonists, therefore, caution is advised in their concomitant use (see section 4.4).
Maltese: Trattament flimkien ma' derivati ta' methylxanthine, sterojdi jew dijuretiċi li jħallu l-potassju joħroġ fl-awrina tista' żżid l-effett ipokalimiku inizjali possibbli ta' agonisti adrenerġiċi β2, għalhekk, hija rrakkomandata kawtela fl-użu konkomitanti tagħhom (ara sezzjoni 4.4).
English: Following inhaled administration of Bevespi Aerosphere in subjects with COPD, glycopyrronium Cmax occurred at approximately 5 minutes, and formoterol Cmax occurred within 20 to 60 minutes.
Maltese: Aerosphere f'individwi b'COPD, is-Cmax ta' glycopyrronium seħħet wara madwar 5 minuti, u s-Cmax ta' formoterol seħħet fi żmien 20 sa 60 minuta.
English: Table 2 Lung function, symptomatic and health related quality of life outcomes over 24 weeks Treatment comparisons with Bevespi
Maltese: Ma twettqux studji kliniċi ta' interazzjoni mediċinali b'Bevespi
English: There were improvements in trough FEV1 irrespective of age, sex, degree of airflow limitation, baseline symptoms, smoking status, or inhaled corticosteroid use.
Maltese: Kien hemm titjib fl-FEV1 minimu irrispettivament mill-età, is-sess, il-grad ta' limitazzjoni tal-fluss talarja, is-sintomi fil-linja bażi, l-istat ta' tipjip jew l-użu ta' kortikosterojdi li jittieħdu man-nifs.
English: EXP
Maltese: Aerosphere
English: How to store Bevespi Aerosphere Contents of the pack and other information Instructions for use
Maltese: Aerosphere Kontenut tal-pakkett u informazzjoni oħra Struzzjonijiet għall-użu
English: Bevespi Aerosphere comes as a pressurised container with a dose indicator, supplied with a white plastic actuator body and mouthpiece (see Figure 1 of the Instructions for Use at the end of this leaflet).
Maltese: Aerosphere jiġi bħala kontenitur taħt pressjoni b'indikatur tad-doża, fornit b'qafas ta' azzjonatur tal-plastik abjad u biċċa tal-ħalq (ara Figura 1 tal-Istruzzjonijiet għall-Użu fi tmiem dan ilfuljett).
English: Patients with clinically significant uncontrolled cardiovascular disease were excluded from clinical studies.
Maltese: Il-pazjenti b'mard kardjovaskulari mhux ikkontrollat klinikament sinifikanti kienu esklużi mill-istudji kliniċi.
English: Priming your Bevespi Aerosphere inhaler:
Maltese: Kif tuża l-inalatur tiegħek ta' Bevespi Aerosphere:
English: SLO - 1001 Ljubljiana Slovenia
Maltese: SLO - 1001 Ljubljiana Slovenja
English: 20068 Peschiera Borromeo (MI) Italy
Maltese: 20068 Peschiera Borromeo (MI) L-Italja
English: Sardenya 346 - 350 E - 08025 Barcelona Spain
Maltese: Sardenya 346 - 350 E - 08025 Barcelona Spanja
English: Kruczkowskiego, 8 00 - 380 Warszawa Poland
Maltese: Kruczkowskiego, 8 00 - 380 Warszawa Il-Polonja
English: 08918 Badalona (Barcelona) Spain
Maltese: 08918 Badalona (Barcelona) Spanja
English: UCB Pharma GmbH (AT) Jacquingasse,16-18/3.OG 1030 Wien
Maltese: UCB Pharma GmbH (AT) Jacquingasse,16-18/3.OG 1030
English: 31-546 Krakow Poland
Maltese: 31-546 Krakow Il-Polonja
English: Avenida de Barcelona, 239 08750 Molins de Rei (Barcelona) Spain
Maltese: Avenida de Barcelona, 239 08750 Molins de Rei (Barcelona) Spanja
English: UCB Magyarország Kft Árpád fejedelem útja 26-28 1023 Budapest Hungary
Maltese: UCB Magyarország Kft Árpád fejedelem útja 26-28 1023
English: Belgium McNeil Roderveld 1
Maltese: Il-Lussemburgu McNeil Roderveld 1
English: UCB GmbH Alfred-Nobel-Str. 10 D-40789 Monheim Germany
Maltese: UCB GmbH Alfred-Nobel-Str. 10 D-40789 Monheim
English: Creatinine clearance (ml/min)
Maltese: Grupp clearance tal-krejatinina (ml/min)
English: UCB A.E. 580 Avenue Vouliagmenis GR-16452 Argyroupoli Athens
Maltese: Avenue Vouliagmenis GR-16452 Argyroupoli Athens
English: United Kingdom: Benadryl allergy oral syrup, Benadryl for children allergy solution, Zirtek allergy relief for children, Zirtek allergy solution, Benadryl allergy solution, Benadryl allergy oral solution
Maltese: Ir-Renju Unit: Benadryl allergy oral syrup, Benadryl for children allergy solution, Zirtek allergy relief for children, Zirtek allergy solution, Benadryl allergy solution, Benadryl allergy oral solution
English: D-76139 Karlsruhe GERMANY
Maltese: D-76139 Karlsruhe IL-ĠERMANJA
English: Quinta da Fonte 2770-229 Paco de Arcos Portugal
Maltese: Quinta da Fonte 2770-229 Paco de Arcos Il-Portugall
English: McNeil Products Limited Foundation Park, Roxborough way, Maidenhead, Berkshire, SL6 3UG, UK
Maltese: McNeil Products Limited Foundation Park, Roxborough way, Maidenhead, Berkshire, SL6
English: FI-00700 HELSINKI
Maltese: FI-00700
English: Rare: urticaria
Maltese: Rari: urtikarja,
English: United Kingdom: Benadryl one a day, Benadryl one a day relief, Zirtek allergy relief tablets
Maltese: Ir-Renju Unit: Benadryl one a day, Benadryl one a day relief, Zirtek allergy relief tablets
English: UCB Pharma SpA Via Praglia, I-10044 Pianezza (Torino)
Maltese: UCB Pharma SpA Via Praglia, I-10044
English: Contra-indicated
Maltese: Kontra-indikat
English: Sanofi Aventis France 9 Boulevard Romain Rolland 75159 Paris Cedex 14 France
Maltese: France 9 Boulevard Romain Rolland 75159 Paris Cedex 14 Franza
English: B - 2600 Berchem Belgium
Maltese: B - 2600 Berchem Il-Belġju
English: UCB Farchim S.A. (AG, Ltd) Z.I.
Maltese: UCB Farchim S.A. (AG, Ltd) Z.I. de Planchy
English: Spain: Alerlisin, Virlix, Reactine, Zyrtec comprimidos recubiertos con pelicula, Alerrid 10 mg comprimidos recubiertos con pelicula
Maltese: Alerlisin, Virlix, Reactine, Zyrtec comprimidos recubiertos con pelicula, Alerrid 10 mg comprimidos recubiertos con pelicula
English: Medis Podjetje za proizvodnjo in trzenje, D.O.O.
Maltese: Medis Podjetje za proizvodnjo in trzenje, D.O.O. (Slovenia) Brnciceva 1
English: Plasma protein binding of cetirizine is 93 ± 0.3 %.
Maltese: Ir-rabta ta' proteini fil-plażma ta' cetirizine hija ta' 93 ± 0.3 %.
English: Placebo (n =1294)
Maltese: Plaċebo (n =1294)
English: ZIRTEK ALLERGY RELIEF TABLETS
Maltese: ZIRTEK ALLERGY RELIEF
English: CH-1630 Bulle
Maltese: Ch. de Croix-Blanche 10 CH-1630 Bulle
English: UCB Nordic A/S Arne Jacobsens Allé 15 DK-2300 Kobenhavn S Denmark
Maltese: UCB Nordic A/S Arne Jacobsens Allé 15 DK-2300
English: - Colloidal anhydrous silica - Magnesium stearate - Opadry Y-1-7000 - Hydroxypropylmethylcellulose (E 464) - Titanium dioxide (E 171) - Macrogol 400
Maltese: - Microcrystalline cellulose - Lactose - Colloidal anhydrous silica - Magnesium stearate - Opadry Y-1-1700 - Hydroxypropylmethylcellulose (E 464) - Titanium dioxide (E 171) - Macrogol 400
English: 04010 Borgo San Michele (LT) Italy
Maltese: Borgo San Michele (LT) L-Italja
English: Placebo (n = 3061)
Maltese: Plaċebo (n = 3061)