FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, the comparison of these PK data with PD data, Study FLT3503, shows that despite the lower relative bioavailability of fluticasone propionate in this new fixed-dose combination product the effect upon predose FEV1 (which was demonstrably mediated by fluticasone propionate alone in Study FLT3503) was numerically greater with Flutiform 500µg/20µg than with GSK fluticasone propionate 500µg (either administered alone or administered together with Novartis formoterol fumarate 24µg).
Maltese: din id-dejta PK mad-dejta PD, Studju FLT3503, juri li minkejja l-bijodisponibbiltà relattiva aktar baxxa ta' fluticasone propionate f'dan il-prodott ġdid ikkombinat f'doża fissa l-effett fuq l-FEV1 ta'
English: Overall summary of the scientific evaluation of Flutiform and associated names (see Annex I)
Maltese: Sommarju globali tal-evalwazzjoni xjentifika ta' Flutiform u ismijiet assoċjati (ara Anness I)
English: The products are orally inhaled products and the combined therapy of an inhaled glucocorticosteroid and a selective long-acting ß2 adrenergic agonist is well established for use in the regular treatment of adults and children with asthma where the use of such a combination is deemed appropriate.
Maltese: Il-prodotti huma prodotti li jittieħdu man-nifs mill-ħalq u l-kura kkombinata ta' glukokortosterojde li jittieħed man-nifs u agonista adrenerġiku ß2 selettiv li jaġixxi fit-tul hija stabbilita sew għall-użu filkura regolari ta' adulti u tfal li jbatu bl-ażżma fejn l-użu ta' kombinazzjoni bħal din hija meqjusa xierqa.
English: D-40211 Düsseldorf
Maltese: D-40211 Düsseldorf Germany
English: 92927 La Défense Cedex France
Maltese: 92927 La Défense Cedex Franza
English: Date of latest renewal: 22 November 2018
Maltese: Data tal- aħħar tiġdid : 22 ta' Novembru 2018
English: Gel 2g 10 g 30 g
Maltese: Ġell 2g 10 g 30 g
English: Study 1 + Study 2
Maltese: Studju 1 + Studju 2
English: Mirvaso Gel n=79
Maltese: Ġell Mirvaso n=79
English: Polyethylene (PE)/Copolymer/Aluminium (Al)/Copolymer/Polyethylene (PE) polyfoil tubes: EU/1/13/904/004
Maltese: Tubi tal-polifojl tal-Polyethylene (PE)/Kopolimer/Aluminju (Al)/Kopolimer/Polyethylene (PE) EU/1/13/904/004
English: Angioedema*
Maltese: Anġjoedema*
English: Galderma Italia S.p.A. Tel: + 39 039 63 4691
Maltese: Tel: + 39 039 63 4691
English: Children aged less than 2 years.
Maltese: Tfal ta' età inqas minn sentejn.
English: Toulouser Allee 19a-23a
Maltese: Galderma Laboratorium GmbH Toulouser Allee 19a-23a
English: UNIQUE IDENTIFIER - 2D BARCODE
Maltese: IDENTIFIKATUR UNIKU BARCODE 2D 18.
English: Mirvaso Gel n=127
Maltese: Ġell Mirvaso n=127
English: Tel. +356 21461851, +356 21460164 e-mail:info@prohealth.com.mt
Maltese: +356 21461851, +356 21460164 e-mail: info@prohealth.com.mt
English: Tube of 2g
Maltese: TUBU ta' 2 g
English: INFORMATION IN BRAILLE Mirvaso
Maltese: INFORMAZZJONI BIL-BRAILLE Mirvaso
English: Mirvaso Gel n=142
Maltese: Ġell Mirvaso n=142
English: Table 1 - Adverse reactions
Maltese: Tabella 1: Reazzjonijiet avversi
English: Mirvaso 3 mg/g gel brimonidine
Maltese: Mirvaso 3 mg/g ġell brimonidine
English: Mirvaso is contraindicated in children aged less than 2 years because of serious systemic safety risk (see section 4.3).
Maltese: Mirvaso huwa kontraindikat fi tfal b'età inqas minn sentejn minħabba riskju serju ta' sigurtà sistemika (ara sezzjoni 4.3).
English: What Mirvaso contains - The active substance is brimonidine.
Maltese: X'fih Mirvaso - Is-sustanza attiva hi brimonidine.
English: One gram of gel contains 1 mg methylparahydroxybenzoate (E218) and 55 mg propylene glycol (E1520).
Maltese: Gramma waħda ta' ġell fiha 1 mg ta' methylparahydroxybenzoate (E218) u 55 mg ta' propylene glycol (E1520).
English: Brimonidine is a highly selective alpha2-adrenergic receptor agonist that is 1000-fold more selective for the alpha2-adrenergic receptor than the alpha1-adrenergic receptor.
Maltese: Brimonidine huwa agonista selettiv ħafna tar-riċettur alfa2 adrenerġiku li huwa 1000 darba aktar selettiv għar-riċettur alfa2 adrenerġiku milli għar-riċettur alfa1 adrenerġiku.
English: Galderma Laboratorium GmbH
Maltese: H. Abbe Pharma GmbH atstovybė
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 February 2014
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 21 ta' Frar 2014
English: Galderma Polska Sp. z o.o.
Maltese: Galderma Italia S.p.A.
English: After repeated cutaneous application of Mirvaso on facial skin, no drug accumulation in plasma was observed throughout the treatment duration: the highest mean (± standard deviation) plasma maximum concentration (Cmax) and area under the concentration-time curve from 0 to 24 hours (AUC0-24hr) were 46 ± 62 pg/mL and 417 ± 264 pg.hr/mL respectively.
Maltese: Wara applikazzjoni ripetuta ta' Mirvaso fuq il-ġilda tal-wiċċ, ma ġiet osservata l-ebda akkumulazzjoni tal-mediċina fil-plażma matul il-perjodu kollu ta' kura: l-ogħla medja (± devjazzjoni standard) tal-konċentazzjoni massima fil-plażma (Cmax) u l-erja taħt il-kurva tal-konċentrazzjoni-ħin minn 0 sa 24 siegħa (AUC0-24siegħa) kienu ta' 46 ± 62 pg/mL u 417 ± 264 pg.siegħa/mL rispettivament.
English: Uncommon Headache, paraesthesia
Maltese: Uġigħ ta' ras, parasteżija
English: CEA and PSA were defined as follows:
Maltese: CEA u PSA ġew definiti kif ġej:
English: * Adverse reactions reported from post-marketing data.
Maltese: * Reazzjonijiet avversi rrapportati minn dejta ta' wara t-tqegħid fis-suq.
English: 74540 Alby-sur-Chéran
Maltese: Alby-sur-Chéran Franza
English: CEA: Clinician Erythema Assessment: 0=Clear skin with no signs of erythema, 1=Almost clear; slight redness, 2=Mild erythema; definite redness, 3=Moderate erythema+ marked redness and 4=Severe erythema+ fiery redness
Maltese: Valutazzjoni tal-Eritema mit-Tabib: 0=Ġilda ċara mingħajr sinjali ta' eritema, 1=Kważi ċara; ftit ħmura, 2=Eritema ħafifa; ħmura definita, 3=Eritema moderata+ ħmura konsiderevoli u 4=Eritema severa+ ħmura severa
English: Pharmacotherapeutic group: Other dermatological preparations, Other dermatologicals, ATC code: D11AX21.
Maltese: Kategorija farmakoterapewtika: Preparazzjonijiet dermatoloġiċi oħrajn, Dermatoloġiċi oħra, Kodici ATC:
English: The adverse reactions are classified by System Organ Class and frequency, using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to <1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data) and were reported with Mirvaso either in clinical studies, or during the post-marketing experience (identified by an asterix (*) in Table 1).
Maltese: Ir-reazzjonijiet avversi huma kklassifikati skont is-Sistema tal-Klassifika tal-Organi u l-frekwenza, bl-użu tal-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-dejta disponibbli) u kienu rrappurtati b'Mirvaso jew fi studji kliniċi, jew f`esperjenzi li ġew identifikati wara li l-prodott tqiegħed fuq is-suq (murija b`* fit Tabella 1.
English: One gram of gel contains 3.3 mg of brimonidine, equivalent to 5 mg of brimonidine tartrate.
Maltese: Gramma waħda ta' ġell fiha 3.3 mg ta' brimonidine, ekwivalenti għal 5 mg ta' brimonidine tartrate.
English: Mirvaso contains: - Methylparahydroxybenzoate (E218) which may cause allergic reactions (possibly delayed).
Maltese: Mirvaso fih: - Methylparahydroxybenzoate (E218) li jista' jikkawża reazzjonijiet allerġiċi (possibbilment ittardjati).
English: The most commonly reported adverse reactions are erythema, pruritus, flushing and skin burning sensation, all occurring in 1.2 to 3.3% of patients in clinical studies.
Maltese: Ir-reazzjonijiet avversi irrappurtati bl-aktar mod komuni huma eritema, ħakk, fwawar u sensazzjoni ta' ħruq fil-ġilda, li lkoll iseħħu f'1.2 sa 3.3% tal-pazjenti fi studji kliniċi.
English: Erythema, pruritus, rosacea, skin burning sensation
Maltese: Eritema, ħakk, sensazzjoni ta' ħruq fil-ġilda, rosaċea
English: Tube of 10 g and 30g
Maltese: Tubu ta` [10 g; 30 g]
English: The absorption of brimonidine from Mirvaso was evaluated in a clinical study in 24 adult subjects with facial erythema of rosacea.
Maltese: L-assorbiment ta' brimonidine minn Mirvaso kien evalwat fi studju kliniku fuq 24 individwu adult b'eritema ta' rosaċea fil-wiċċ.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One gram of gel contains 3.3 mg of brimonidine, equivalent to 5 mg of brimonidine tartrate.
Maltese: U KWANTITATTIVA Gramma waħda ta' ġell fiha 3.3 mg ta' brimonidine, ekwivalenti għal 5 mg ta' brimonidine tartrate.
English: Tel.: + 48 22 331 21 80 e-mail: info.poland@galderma.com
Maltese: Galderma Polska Sp. z o.o. Tel.: + 48 22 331 21 80 e-mail: info.poland@galderma.com
English: However, in the long term open label study, the efficacy and safety of Mirvaso, as described above, was not affected by the concomitant use of cosmetics or other medicinal products (e.g. topical metronidazole, topical azelaic acid, and oral tetracyclines including low dose doxycycline) for the treatment of inflammatory lesions of rosacea in the concerned subpopulation (131/449 patients in the study used concomitant rosacea medicinal product).
Maltese: Madankollu, fl-istudju fit-tul open label, l-effikaċja u s-sigurtà ta' Mirvaso, kif deskritt fuq, ma kinux affettwati mill-użu fl-istess ħin ta' kosmetiċi jew prodotti mediċinali oħra (eż. Metronidazole topikali, azelaic acid topikali, u tetracyclines orali, inkluż doxycycline ta' doża baxxa) għall-kura ta' feriti infjammatorji ta' rosaċea fis-sottopopolazzjoni kkonċernata (131/449 pazjent fl-istudju użaw prodott mediċinali għal rosacea fl-istess ħin).
English: Pack sizes: 1 tube of 2 g,10 g or 30 g; 1 pump of 30 g. Not all pack sizes may be marketed.
Maltese: Daqsijiet tal-pakkett: tubu wieħed ta' 2g, 10 g jew 30 g; pompa waħda ta' 30 g.
English: In addition, for the overall population, Mirvaso demonstrated statistical superiority (p<0.001) over vehicle gel with respect to rapid initial onset of a clinically meaningful effect (1-Grade Composite Success for CEA and PSA) after the first application at 30 minutes on Day 1(secondary endpoint 27.9% vs. 6.9% for Study 1, 28.4% vs. 4.8% for Study 2), and to achievement of a clinically meaningful effect (1-Grade Composite Success for CEA and PSA) on Day 29 (tertiary endpoint, see Table 4).
Maltese: Għas-subsett tal-popolazzjoni ta' pazjenti b'eritema severa f'Jum 1 linja bażi (jiġifieri individwi bi grad CEA jew PSA ta' 4) li rrappreżentaw 26% tal-individwi randomizzati, ir-riżultati fuq il-punt ta' tmiem primarju f'Jum 29 kienu simili għal dawk ir-riżultati osservati fil-popolazzjoni ġenerali (ara Tabella 3) u kienu statistikament sinifikanti għaż-żewġ studji kkombinati (p=0.003). Barra minn hekk, għall-popolazjzoni ġenerali, Mirvaso wera superjorità statistika (p<0.001) fuq il-ġel mingħajr sustanza attiva rigward bidu inizjali mgħaġġel ta' effett kliniku sinifikanti (Suċċess Kompost ta' Grad 1 għal CEA u PSA) 30 minuta wara l-ewwel applikazzjoni f'Jum 1 (punt ta' tmiem sekondarju 27.9% vs. 6.9% għal Studju 1, 28.4% vs. 4.8% għal Studju 2), u biex jikseb effett kliniku sinifikanti (Suċċess Kompost ta' Grad 1 għal CEA u PSA) f'Jum 29 (punt ta' tmiem terzjarju, ara Tabella 4).
English: Concomitant use of other systemic alpha adrenergic receptor agonists The concomitant use of other systemic alpha adrenergic receptor agonists may potentiate the undesirable effects of this class of medicinal products in patients: - with severe or unstable or uncontrolled cardiovascular disease; - with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension, thrombangiitis obliterans, scleroderma, or Sjögren's syndrome.
Maltese: L-użu fl-istess ħin ta` alpha adrenergic receptor agonists sistematiċi jista` jsaħħah l-effetti mhux mixtieqa ta` din il-klassi ta` prodotti mediċinali f`pazjenti : - B` problemi severi kardio-vaskulari , jew li mhumiex kkontrollati jew li mhumiex stabbli - Li jbatu b` dipressjoni, nuqqas ta` ċirkolazzjoni fil-qalb jew fil-moħħ, Raynaud`s phenomenon, orthostatic hypertension, thrombangitis obliterans, sclerodema jew Sjorgen`s syndrome.
English: e-mail: info.be@galderma.com
Maltese: 45 46 e-mail: pharmacovigilance.france@galderma.com
English: Mirvaso is contraindicated in patients receiving monoamine oxidase (MAO) inhibitor therapy and patients on tricyclic or tetracyclic antidepressants which affect noradrenergic transmission (see section 4.3).
Maltese: Mirvaso huwa kontraindikat f'pazjenti li jirċievu terapija ta' inibituri ta' monoamine oxidase (MAO) u pazjenti fuq antidepressanti triċikliċi jew tetraċikliċi li jaffettwaw it-trasmissjoni noradrinerġika (ara sezzjoni 4.3).
English: Overdoses after oral use of other alpha2-agonists have been reported to cause symptoms such as hypotension, asthenia, vomiting, lethargy, sedation, bradycardia, arrhythmias, miosis, apnoea, hypotonia, hypothermia, respiratory depression and seizure.
Maltese: Dożi eċċessivi wara użu orali ta' agonisti alfa2 oħra ġew irrappurtati li jikkawżaw sintomi bħal pressjoni baxxa, astenja, rimettar, letarġija, ngħas, bradikardija, arritmija, mijosi, apnea, ipotonija, ipotermja, dipressjoni respiratorja u aċċessjoni.
English: Of these, 539 completed 29 days of treatment and had data available to be included in the efficacy analysis at Day 29, with the majority being Caucasians between 18 and 65 years of age.
Maltese: Minn dawn, 539 temmew 29 jum ta' kura u kellhom dejta disponibbli sabiex tkun inkluża fl-analiżi tal-effikaċja f'Jum 29, li l-maġġoranza kienu Kawkażi b'età minn 18 sa 65 sena.
English: See also section 2 under ‘Warnings and precautions'.
Maltese: Ara wkoll sessjoni 2 taħt “Twissijiet u Prekawzjonijiet”
English: - Propylene glycol (E1520) which may cause skin irritation.
Maltese: - Propylene glycol(E1520) li jista' jikkawża irritazzjoni fil-ġilda.
English: Uncommon Acne, allergic contact dermatitis, contact dermatitis, dermatitis, dry skin, pain of skin, skin discomfort, rash papular, skin irritation, skin warm, swelling face*, urticaria*
Maltese: Akne, dermatite allerġika tal-kuntatt, dermatite ta' kuntatt, dermatite, ġilda xotta, uġigħ fil-ġilda, skumdità fil-ġilda, raxx papulari, irritazzjoni fil-ġilda, ġilda tinħass sħuna, nefħa fil-wiċċ*, ħakk*
English: Mirvaso with alcohol
Maltese: Mirvaso mal-alkoħol
English: The onset of flushing relative to application of Mirvaso topical gel varied, ranging from approximately 30 minutes to several hours (see section 4.8).
Maltese: Il-bidu ta' fawra relattiva għall-applikazzjoni ta' Mirvaso ġel għal fuq il-ġilda varja, minn madwar 30 minuta sa diversi sigħat (ara sezzjoni 4.8).
English: The safety and efficacy of Mirvaso in children and adolescents aged less than 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Mirvaso fi tfal u adolexxenti minn età inqas minn 18-il sena ma ġewx determinati s'issa.
English: Gel 30 g
Maltese: Ġell 30 g
English: NAME OF THE MEDICINAL PRODUCT Mirvaso 3 mg/g gel
Maltese: Mirvaso 3 mg/g ġell
English: Other medicines and Mirvaso
Maltese: Mediċini oħra u Mirvaso
English: The primary endpoint was expressed in terms of composite success i.e. subjects responding with a 2-grade reduction on both baseline CEA score and baseline PSA score on Day 29.
Maltese: Il-punt finali primarju kien espress f'termini ta' suċċess kompost, jiġifieri individwi li rrispondew bi tnaqqis ta' 2 gradi kemm fil-punteġġ tas-CEA linja bażi kif ukoll fil-punteġġ tal-PSA linja bażi f'Jum 29.
English: Biotransformation Brimonidine is extensively metabolised by the liver.
Maltese: Bijotrasformazzjoni Brimonidine huwa metabolizzat b'mod estensiv mill-fwied.
English: Tour Europlaza, 20 avenue André Prothin - La Défense 4 La Défense Cedex 92927
Maltese: Tour Europlaza, 20 avenue André Prothin - La
English: PSA: Patient Self-Assessment: 0=No redness, 1=Very mild redness, 2=Mild redness, 3=Moderate redness and 4=Severe redness
Maltese: Valutazzjoni mill-Pazjent Innifsu: 0=Ebda ħmura, 1=ħmura ħafifa ħafna, 2=ħmura ħafifa, 3=ħmura moderata u 4=ħmura severa
English: Mirvaso can be used in conjunction with other cutaneous medicinal products for the treatment of inflammatory lesions of rosacea and with cosmetics.
Maltese: Mirvaso jista' jintuża flimkien ma' prodotti mediċinali tal-ġilda oħra għall-kura ta' feriti infjammatorji ta' rosaċea u ma' prodotti kosmetiċi.
English: Across all clinical studies, 16% of patients receiving Mirvaso experienced an event of symptom exacerbation.
Maltese: Tul l-istudji kliniċi kollha, 16 % tal-pazjenti li rċevew Mirvaso esperjenzaw episodju ta' taħrix tas-sintomi.
English: Propylene glycol (E1520) Sodium hydroxide Purified water
Maltese: Propylene glycol (E1520)
English: It is important not to exceed the maximum daily dose of 1gram (5 pea sized amounts applied to the whole face).
Maltese: Huwa importanti li ma taqbiżx id-doża massima ta' kuljum ta' 1 g ramma(5 ammonti d-daqs ta' piżella applikati għall-wiċċ kollu).
English: The requirements for submission of periodic safety reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequently updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: Patients receiving monoamine oxidase (MAO) inhibitor therapy (for example selegiline or moclobemide) and patients on tricyclic (such as imipramine) or tetracyclic (such as maprotiline, mianserin or mirtazapin) antidepressants which affect noradrenergic transmission.
Maltese: Pazjenti li jirċievu terapija ta' inibituri ta' monoamine oxidase (MAO) (eżempju selegiline jew moclobemide) u pazjenti fuq antidepressanti triċikliċi (bħal imipramine) jew tetraċikliċi (bħal maprotiline, mianserin jew mirtazapin) li jaffettwaw it-trasmissjoni noradrinerġika.
English: H. Abbe Pharma GmbH atstovybė Tel: +370/52/711710 e-mail: info@abbepharma.lt
Maltese: Tel: +370/52/711710 e-mail: info@abbepharma.lt
English: If you develop uncommon side effects of severe skin irritation or inflammation, skin rash, skin pain or discomfort, dry skin, warm skin sensation, tingling or sensation of pins and needles or swelling of the face or common side effects like worsening of rosacea, discontinue the treatment and talk to your doctor since this medicine may not be suitable for you.
Maltese: - Jekk tiżviluppa effetti sekondarji mhux komuni ta` irritazzjoni severa tal.ġilda, jew infjammazzjoni, raxx fil-ġilda, uġigħ jew skumdità fil-ġilda, ġilda xotta, sensazzjoni ta' ġilda sħuna, tnemnim jew sensazzjoni ta' li qed jorqdulek partijiet minn ġismek jew nefħa tal-wicc jew effetti sekondarji komuni bhal irkadar ta` rosacea, waqqaf it-trattament u kellem lit-tabib tiegħek għaliex din il-medicina tista` ma tkunx tajba għalik.
English: Elimination Urinary excretion is the major route of elimination of brimonidine and its metabolites.
Maltese: Eliminazzjoni Tneħħija fl-awrina hija r-rotta ewlenija tal-eliminazzjoni ta' brimonidine u tal-metaboliti tiegħu.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One gram of gel contains 3.3 mg of brimonidine.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Gramma waħda ta' ġell fiha 3.3 mg ta' brimonidine.
English: Aggravated erythema, flushing and skin burning sensation have been reported during the post-marketing period (see section 4.4).
Maltese: Ġew irrapportati eritema, fwawar u sensazzjoni ta' ħruq tal-ġilda aggravati waqt il-perjodu ta' wara t-tqegħid fis-suq (ara sezzjoni 4.4).
English: Z.I.
Maltese: C.
English: If you develop contact allergy (e.g. allergic reaction, rash) or rare angioedema (a serious allergic reaction see rarely usually with swelling of the face, mouth or tongue), stop using Mirvaso and seek prompt medical advice.
Maltese: Jekk tiżviluppa allerġija tal-kuntatt (per eżempju reazzjoni allerġika jew raxx),jew angioedema rari (reazzjoni allerġika serja, normalment b'nefħa tal-wiċċ, ħalq jew ilsien) waqqaf ittrattament tal- Mirvaso u fittex għajnuna medika
English: 3 hours after application 70.9% 6 hours after application 69.3% 9 hours after application 63.8% 12 hours after application 56.7% Day 29 p-value
Maltese: 12-il siegħa wara l-applikazzjoni 56.7% 30.5% 53.5% 40.1% Valur p f'jum 29
English: Excipients: Carbomer, methylparahydroxybenzoate (E218), phenoxyethanol, glycerol, titanium dioxide, propylene glycol, sodium hydroxide, purified water.
Maltese: Eċċipjenti: Carbomer, methylparahydroxybenzoate (E218), phenoxyethanol, glycerol, titanium dioxide, propylene glycol, sodium hydroxide, ilma ppurifikat.
English: Magyarország Ewopharma Hungary Kft. Tel.: +36 1 200 4650 e-mail: info@ewopharma.hu
Maltese: +36 1 200 4650 e-mail: info@ewopharma.hu
English: Vehicle Gel n=63
Maltese: Ġell mingħajr sustanza attiva n=63
English: Excipients: Carbomer, methylparahydroxybenzoate (E218), phenoxyethanol, glycerol, titanium dioxide, propylene glycol (E1520), sodium hydroxide, purified water.
Maltese: Eċċipjenti: Carbomer, methylparahydroxybenzoate (E218), phenoxyethanol, glycerol, titanium dioxide, propylene glycol (E1520) , sodium hydroxide, ilma ppurifikat.
English: Uncommon Eyelid oedema
Maltese: Populazzjonijiet Oħra Speċjali
English: Erythema and flushing
Maltese: Eritema u Fwawar
English: And
Maltese: JIS
English: It is supplied in tubes containing 2, 10 or 30 grams of gel or in airless pump system containing 30 g of gel.
Maltese: Huwa disponibbli f'tubi li fihom 2, 10 jew 30 gramma ta' ġell jew f'sistema ta' pompa mingħajr arja li fiha 30 g ta' ġell.
English: Polyethylene (PE)/Copolymer/Aluminium (Al)/Copolymer/Polyethylene (PE) polyfoil tubes with a high density polyethylene (HDPE) head and polypropylene (PP) child resistant closure.
Maltese: Tubi tal-polifojl tal-Polyethylene (PE)/Kopolimer/Aluminju (Al)/Kopolimer/Polyethylene (PE) bil-parti ta' quddiem magħmula minn polyethylene ta' densità għolja (HDPE - high density polyethylene) u għatu li ma jinfetaħx mit-tfal magħmul minn polypropylene (PP).
English: No meaningful differences in the safety profiles were observed between the elderly subject population and subjects 18 to 65 years of age.
Maltese: Ma dehru l-ebda differenzi fil-profil tas -sigurta` tal-prodott bejn il-populazzjoni anzjan u pazjenti ta` bejn it-18 u l-65 sena
English: Safety concerns related to the systemic absorption of brimonidine have also been identified for the age group 2 to 12 years (see section 4.9).
Maltese: Tħassib dwar is-sigurtà relatat mal-assorbiment sistemiku ta' brimonidine ġie identifikat ukoll għall-grupp ta' età ta' bejn sentejn u 12-il sena (ara sezzjoni 4.9).
English: Brimonidine may cause clinically insignificant decreases in blood pressure in some patients.
Maltese: F'xi pazjenti, brimonidine jista' jikkawża tnaqqis mhux klinikament sinifikanti fil-pressjoni tad-demm.
English: The results from both clinical studies demonstrated that Mirvaso was significantly more effective (p<0.001) in the reduction of facial erythema of rosacea than vehicle gel when applied once daily for 29 days (primary endpoint, see Table 2).
Maltese: Ir-riżultati miż-żewġ studji kliniċi wrew li Mirvaso kien ferm aktar effettiv (p<0.001) biex inaqqas l-eritema ta' rosaċea fil-wiċċ minn ġell mingħajr sustanza attiva meta applikat darba kuljum għal 29 ġurnata (punt ta' tmiem primarju, ara Tabella 2).
English: Vehicle Gel n=128
Maltese: Ġell mingħajr sustanza attiva n=128
English: Bradycardia and hypotension
Maltese: Bradikardija u pressjoni baxxa
English: Do not swallow.
Maltese: Ilma ppurifikat
English: Mirvaso contains the active substance brimonidine which belongs to a group of medicines commonly referred to as “alpha agonists”.
Maltese: Mirvaso fih is-sustanza attiva brimonidine li tagħmel parti minn grupp ta' mediċini magħrufa b'mod komuni bħala “agonisti alfa”.