FrancophonIA/ELRC3.0 huggingface dataset:
English: Rare: convulsions, movements disorders Very rare: dysgeusia, syncope, tremor, dystonia, dyskinesia
Maltese: Rari: aċċessjonijiet, mard tal-moviment Rari ħafna: disġewsja, sinkope,rogħda, distonja, diskinesja
English: Hepatically impaired patients: Patients with chronic liver diseases (hepatocellular, cholestatic, and biliary cirrhosis) given 10 or 20 mg of cetirizine as a single dose had a 50 % increase in half-life along with a 40 % decrease in clearance compared to healthy subjects.
Maltese: Pazjenti b'indeboliment tal-fwied: Pazjenti b'mard kroniku tal-fwied (epato-cellulari, kolestatiku u ċirrożi tal-marrara) li ngħataw 10 mg jew 20 mg ta' cetirizine bħala doża waħda kellhom 50 % żieda fil-half-life flimkien ma' tnaqqis ta' 40 % tal-clearance meta mqabbla ma' suġġetti f'saħħithom.
English: Denmark: Benaday, Zyrtec
Maltese: Benaday, Zyrtec
English: One ml (equals to 20 drops) contains 10 mg of cetirizine dihydrochloride.
Maltese: Ml wieħed (ekwivalenti għal 20 taqtira) fih 10 mg ta' cetirizine dihydrochloride taqtira waħda fiha 0.5 mg ta' cetirizine dihydrochloride.
English: Adverse events reported after an intake of at least 5 times the recommended daily dose are: confusion, diarrhoea, dizziness, fatigue, headache, malaise, mydriasis, pruritus, restlessness, sedation, somnolence, stupor, tachycardia, tremor, and urinary retention.
Maltese: Effetti mhux mixtieqa rrappurtati wara li tittieħed qwantita` ta' mill-inqas 5 darbiet id-doża irrakkomandata huma: konfuzzjoni, dijareja, sturdament, għeja, uġigħ ta' ras, telqa kbira, mydriasis, ħakk, irrekwitazza, sedazzjoni, ngħas tqil, sturdament, takikardja, rogħda, u żamma ta' l-awrina.
English: Double blind controlled clinical or pharmacoclinical trials comparing cetirizine to placebo or other antihistamines at the recommended dosage (10 mg daily for cetirizine), of which quantified safety data are available, included more than 3200 subjects exposed to cetirizine.
Maltese: Provi kliniċi jew farmakokliniċi kkontrollati double-blind li jqabblu cetirizine mal- plaċebo jew mediċini oħra kontra l-istamina fid-doża rrakkomandata (10 mg kuljum għal cetirizine), fejn sar kejl ta' tagħrif ta' sigurta`, inkludew iżjed minn 3200 persuna li kienu esposti għal cetirizine.
English: • Children aged from 6 to 12 years: 5 mg twice daily (10 drops twice daily).
Maltese: • Tfal ta' bejn 6 u 12-il sena: 5 mg darbtejn kuljum (10 qatriet darbtejn kuljum).
English: Nervous system disorders:
Maltese: Mard tas-sistema nervuża:
English: INFORMATION IN BRAILLE Zyrtec 10 mg tablets
Maltese: INFORMAZZJONI BIL-BRAILLE Zyrtec u ismijiet assoċjati miegħu (ara Anness I) 10 mg pilloli
English: A 5ml Dosing spoon with a line at 2.5 ml is provided with the bottle.
Maltese: Mgħarfa ta' kejl ta' 5 ml b'linja għal 2.5 ml tiġi provduta mal-flixkun.
English: The CHMP agreed with the harmonised text but maintained its lower age limit of 2 years.
Maltese: Is-CHMP qabel mat-test armonizzat iżda żamm l-limitu ta' età inferjuri tiegħu ta' sentejn.
English: Hypersensitivity to the active substance, to any of the excipients, to hydroxyzine or to any piperazine derivatives.
Maltese: Sensittività eċċessiva għas-sustanza attiva, għal xi sustanza mhux attiva, għal hydroxyzine jew għal xi derivattiv ta' piperazine.
English: Central and peripheral nervous system disorders Dizziness
Maltese: Mard tas-sistema nervuża ċentrali u periferali
English: In this leaflet:
Maltese: Jis:
English: - one ml of solution contains 0.15 mg propylparahydroxybenzoate For a full list of excipients, see section 6.1
Maltese: - ml wieħed tas-soluzzjoni fiħ 0.15 mg propylparahydroxybenzoate Għal lista kompleta ta' sustanzi mhux attivi, ara sezzjoni 6.1.
English: France: Virlix, Zyrtec
Maltese: Virlix, Zyrtec
English: The MAH proposed a harmonised text for section 4.4 Special Warnings, as the section was extensively disharmonised and added some warnings regarding the suitability of the formulations for certain age ranges and reflecting the lack of appropriate data on the benefit- risk for children below one year old, restricting the use of film-coated tablets in children aged less than 6 years, the use of the oral solution children aged less than 2 years and the use of the drop formulation in infants and toddlers aged less than 1 year old.
Maltese: Twissijiet Speċjali, minħabba li s-sezzjoni kellha nuqqas ta' armonizzazzjoni estensiv u żied xi twissijiet dwar l-adegwatezza tal-formolazzjonijiet għal ċerti medda ta' età u rrifletta n-nuqqas ta' dejta xierqa fuq il-bilanċ bejn il-benefiċċju u r-riskju għal tfal ta' inqas minn sentejn, u llimita l-użu ta' pilloli miksija b'rita fi tfal ta' inqas minn 6 snin, l-użu tas-soluzzjoni orali fi tfal ta' inqas minn sentejn u l-użu tal-formolazzjoni tal-qtar fit-trabi u t-tfal ta' inqas minn sena.
English: - Skin and subcutaneous tissue disorders: uncommon: pruritus, rash, rare: urticaria, very rare: oedema, fixed drug eruption
Maltese: - Mard tal-ġilda u t-tessut subkutanju: mhux komuni: anġjonewrotiku, ħakk, raxx, rari: urtikarja, rari ħafna:edema, eruzzjoni fissa għall-mediċina
English: In a 35-day study in children aged 5 to 12, no tolerance to the antihistaminic effect (suppression of wheal and flare) of cetirizine was found.
Maltese: Fistudju ta- 35-ġurnata fit-tfal ta' bejn il-5 u t-12-il sena, ma nstabet ebda tolleranza għall-effett ta' cetirizine kontra l-istamina ( biex trażżan il-‘wheal and flare').
English: No signal suggesting an unfavourable benefit/risk ratio for Zyrtec compared to other antihistamines was ever detected in pharmacovigilance during the 22 years on the market; however the MAH would like to retain the contraindication: “Patients with severe renal impairment at less than 10 ml/min creatinine clearance.”
Maltese: Qatt ma nstab li kien hemm xi sinjal li jissuġġerixxi proporzjon mhux favorevoli bejn ir-riskju u l-benefiċċju għal Zyrtec meta mqabbel ma' anti-istamini oħrajn fil-farmakoviġilanza matul it-22 sena li ilu fis-suq; madankollu, il-MAH jixtieq iżomm il-kontraindikazzjoni: “Pazjenti b'insuffiċjenza renali gravi b'rata ta' eliminazzjoni tal-kreatinina inqas minn 10 ml/min.”
English: Adults and adolescents over 12 years of age: 10 mg once daily (20 drops).
Maltese: Adulti u addoloxxenti ‘l fuq minn 12-il sena: 10 mg darba kuljum (20 taqtira).
English: Cetirizine dihydrochloride is the active ingredient of Zyrtec.
Maltese: Cetirizine dihydrochloride huwa s-sustanza attiva ta' Zyrtec .
English: - General disorders and administration site conditions: uncommon: asthenia (extreme fatigue), malaise, rare: oedema (swelling)
Maltese: - Mard ġenerali u kundizzjonijiet ta' mnejn jingħata: mhux komuni: astenja (għeja estrema), telqa, rari: edima (nefħa)
English: Adults and adolescents above 12 years old: 10 mg once daily as 20 drops
Maltese: Adulti u addoloxxenti ‘l fuq minn 12-il sena: 10 mg darba kuljum bħala 20 taqtira.
English: Blood and lymphatic disorders: Very rare: thrombocytopenia
Maltese: Rari ħafna: tromboċitopenja
English: Very rare: angioneurotic oedema, fixed drug eruption
Maltese: Rari: edema anġjonewrotika, eruzzjoni fissa għall-mediċina
English: In a six-week, placebo-controlled study of 186 patients with allergic rhinitis and concomitant mild to moderate asthma, cetirizine 10 mg once daily improved rhinitis symptoms and did not alter pulmonary function.
Maltese: Fi studju ta' sitt ġimgħat ikkontrollat mill-plaċebo ta' 186 pazjent b'rinite allerġika flimkien ma' ażżma ħafifa jew moderata, cetirizine 10 mg darba kuljum taffa s-sintomi tar-rinite u ma biddilx ilfunzjoni tal-pulmun.
English: Patients with moderate to severe renal impairment Patients with moderate renal impairment are recommended to take 5 mg as 10 drops once daily.
Maltese: Huwa rrakkomandat li pazjenti b'indeboliment renali moderat jieħdu 5 mg bħala 10 taqtiriet darba kuljum.
English: The CHMP asked the MAH to revise the wording, restrict and define the indication in rhinoconjunctivitis rather than in conjunctivitis alone and discuss seasonal conjunctivitis, itching and allergic pruritis, severe skin reactions induced by mosquito and atopic dermatitis, as they should be considered as separate entities requiring more supportive data.
Maltese: Is-CHMP talab lill-MAH jirrevedi l-formolazzjoni tal-kliem, jillimita u jiddefinixxi l-indikazzjoni firrinokonġuntivite iktar milli fil-konġuntivite waħidha u talbu wkoll jiddiskuti l-konġuntivite staġjonali, il-ħakk u l-ħakk allerġiku, ir-reazzjonijiet severi tal-ġilda kkawżati minn nemus u d-dermatite atopika, għax dawn għandhom jitqiesu bħala entitajiet separati li jeħtieġu iktar dejta ta' appoġġ.
English: - Investigations: rare: weight increased
Maltese: - Investigazzjonijiet: rari: żieda fil-piż
English: Slovak Republic: Zyrtec gtt por 10mg/ml Slovenia: Zyrtec10 mg/ml peroralne kapljice, raztopina Spain: Alerlisin, Virdos, Zyrtec gotas orales en solución Sweden: Zyrlex
Maltese: Zyrtec u ismijiet assoċjati miegħu (ara Anness I) 10 mg/ml taqtir tal-ħalq, soluzzjoni [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Maltese: Informazzjoni li mhiex klinika, magħmula fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il-ġeni, riskju ta' kanċer, effett tossiku fuq is-sistema riproduttiva, ma turi l-ebda periklu speċjali għall-bnedmin.
English: Due to the divergent national decisions taken by Member States concerning the authorisation of Zyrtec, a number of divergences exist in the product information and a referral was therefore triggered by the European Commission Article 30 of Directive 2001/83/EC as amended in order to harmonise the divergent Product Information texts across the EU.
Maltese: Minħabba d-deċiżjonijiet nazzjonali diverġenti meħudin mill-Istati Membri dwar l-awtorizzazzjoni ta' Zyrtec, hemm għadd ta' diverġenzi fit-tagħrif dwar il-prodott u għalhekk sar riferiment skond l-Artikolu 30 tad-Direttiva 2001/83/KE talKummissjoni Ewropea kif emendat sabiex jiġu armonizzati t-testi diverġenti tat-Tagħrif dwar ilProdott madwar l-UE.
English: Children aged from 2 to 6 years: 2.5 mg twice daily (2.5 ml oral solution twice daily (a half spoon twice daily)).
Maltese: 2.5 mg darbtejn kuljum (2.5 ml soluzzjoni orali darbtejn kuljum (nofs mgħarfa darbtejn kuljum)).
English: For cetirizine very rare clinical data on exposed pregnancies are available.
Maltese: Hemm tagħrif kliniku rari ħafna każi ta' tqala esposti għal cetirizine.
English: oral solution
Maltese: SOLUCIÓN
English: - Blood and lymphatic disorders: very rare: thrombocytopenia (low levels of blood platelets)
Maltese: - Mard tad-demm u tas-sistema limfatika: rari ħafna: tromboċitopenja (livell baxx ta' plejtlets fid-demm)
English: 10 mg once daily
Maltese: 10 mg
English: ZYRTEC SAFT 1mg/ml oral solution
Maltese: ZYRTEC SAFT 1mg/ml
English: Special populations
Maltese: FOR CHILDREN
English: Germany: Zyrtec P tropfen, Zyrtec tropfen Greece: Ziptek
Maltese: Zyrtec P tropfen, Zyrtec tropfen
English: Since cetirizine is mainly excreted via renal route (see section 5.2), in cases no alternative treatment can be used, the dosing intervals must be individualized according to renal function.
Maltese: Peress li cetirizine jitneħħa prinċipalment millkliewi (ara sezzjoni 5.2), f'każi fejn m'hemmx kura alternattiva, l-intervalli ta' bejn doża u oħra jridu jiġu individwalizzati skond il-funzjoni renali.
English: Mostly this resolves upon discontinuation of the treatment with cetirizine dihydrochloride.
Maltese: Dawn ġeneralment jitjiebu meta jitwaqqaf it-trattament b'cetirizine hydrochloride.
English: Patients with severe renal impairment at less than 10 ml/min creatinine clearance.
Maltese: Pazjenti b'indeboliment renali sever bi clearance tal-krejatinina ta' inqas minn 10 ml/min.
English: NAME OF THE MEDICINAL PRODUCT Zyrtec 10 mg film-coated tablets Cetirizine dihydrochloride
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Ml wieħed tas-soluzzjoni fih 10 mg ta' cetirizine dihydrochloride
English: Do not take Zyrtec - if you have a severe kidney disease (severe renal failure with creatinine clearance below 10 ml/min); - if you are known to be hypersensitive to the active substance of Zyrtec, to any of its excipients (other constituents), to hydroxyzine or to any piperazine derivatives (closely related active substances of other medicines).
Maltese: Tieħux Zyrtec : - Jekk għandhekk mard tal-kliewi sever (falliment sever tal-kliewi bil-clearance tal-krejatinina inqas minn 10 ml/min); - jekk inti tbagħti minn sensittività eċċessiva għas-sustanza attiva ta' Zyrtec , għal xi sustanzi mhux attivi (kostitwenti oħra), għal hydroxyzine jew għal xi derattiv ta' piperazine (li jixbħu mill-qrib għal sustanzi attivi ta' mediċini oħra).
English: Children aged from 6 to 12 years: 5 mg twice daily (5 ml oral solution bid (a full spoon twice daily).
Maltese: Tfal ta' bejn is-6 u t-12-il sena: 5 mg darbtejn kuljum (5 ml soluzzjoni orali bid (mgħarfa sħiħa darbtejn kuljum)).
English: Zyrtec 10 mg/mlTropfen oral drops, solution
Maltese: Zyrtec 10 mg/mlTropfen
English: Zyrtec oral solution contain methyl (4-hydroxybenzoate) E 218, propyl (4-hydroxybenzoate) E 216 that may cause allergic reactions (possibly delayed).
Maltese: Zyrtec soluzzjoni orali fih methyl (4-hydroxybenzoate) E 218 u propyl (4-hydroxybenzoate) E 216, li jistgħu jikkawżaw reazzjonijiet allerġiċi (li jistgħu jdumu biex joħorġu).
English: Children aged from 2 to 6 years: 2.5 mg twice daily (5 drops twice daily).
Maltese: 2.5 mg darbtejn kuljum (5 taqtiriet darbtejn kuljum).
English: Important information about some of the ingredients of Zyrtec Zyrtec oral drops solution contain methyl (4-hydroxybenzoate) E 218 propyl (4-hydroxybenzoate) E 216 that may cause allergic reactions (possibly delayed).
Maltese: Tagħrif importanti dwar xi wħud mis-sustanzi ta' Zyrtec Zyrtec soluzzjoni ta' taqtir tal-ħalq fih methyl (4-hydroxybenzoate) E 218 u propyl (4hydroxybenzoate) E 216, li jistgħu jikkawżaw reazzjonijiet allerġiċi (li jistgħu jdumu biex joħorġu).
English: - Eye disorders: very rare: accommodation disorder, blurred vision, oculogyration (eyes having uncontrolled circular movements)
Maltese: rari ħafna: mard ta' akkomodazzjoni, viżżjoni mċajpra, okulogirazzjoni (għajnejn b'moviment ċirkulari mhux kontrollati)
English: - Cetirizine is indicated for the relief of symptoms of chronic idiopathic urticaria.
Maltese: - Cetirizine huwa indikat għas-serħan minn sintomi ta'urtikarja idjopatika kronika.
English: - the Summaries of Products Characteristic, labelling and package leaflet proposed by the Marketing Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee,
Maltese: - is-Sommarji tal-Karatteristiċi tal-Prodotti, it-tikkettar u l-fuljett ta' tagħrif proposti mid-Detentur ta' l-Awtorizzazzjoni tat-Tqegħid fis-Suq ġew ivvalutati abbażi tad-dokumentazzjoni sottomessa u ddiskussjoni xjentifika fi ħdan il-Kumitat,
English: Studies in healthy volunteers show that cetirizine, at doses of 5 and 10 mg strongly inhibits the wheal and flare reactions induced by very high concentrations of histamine into the skin, but the correlation with efficacy is not established.
Maltese: Studji f'voluntiera f'saħħithom juru li cetirizine f'dożi ta' 5 u 10 mg jinibixxi bil-qawwa rreazzjoniijiet tat-tip ‘wheal and flare' minħabba konċentrazzjonijiet għolja ħafna ta' histamine filġilda, iżda l-korrelazzjoni ma' l-effikaċja ma kienx stabbilit.
English: INFORMATION IN BRAILLE Zyrtec 10 mg/ml oral drops
Maltese: INFORMAZZJONI BIL-BRAILLE Zyrtec u ismijiet assoċjati miegħu (ara Anness I) 1 mg/ml soluzzjoni orali
English: 2.5 mg twice daily administered as 5 drops twice daily Patients with moderate to severe renal impairment Patients with moderate renal impairment are recommended to take 5 mg as 10 drops once daily.
Maltese: Huwa irrakkomandat li pazjenti b'indeboliment renali moderat jieħdu 5 mg bħala 10 taqtiriet darba kuljum.
English: The decrease in cetirizine clearance in these elderly volunteers appeared to be related to their decreased renal function.
Maltese: It-tnaqqis fil-clearance ta' cetirizine f'dawn il-voluntiera anzjani deher li kien relatat mat-tnaqqis fil-funzjoni rli kellhom talkliewi.
English: 2.5 mg twice daily as 2.5 ml oral solution (a half-measuring spoon) twice daily Patients with moderate to severe renal impairment Patients with moderate renal impairment are recommended to take 5 mg once daily.
Maltese: 2.5 mg darbtejn kuljum bħala 2.5 ml soluzzjoni orali (nofs mgħarfa tal-kejl) darbtejn kuljum.
English: Children between 6 and 12 years old: 5 mg twice daily as 10 drops twice daily.
Maltese: Tfal ta' bejn is-6 u t-12-il sena: 5 mg darbtejn kuljum bħala 10 taqtiriet, darbtejn kuljum.
English: The following indications were agreed upon:
Maltese: L-effeti mhux mixtieqa li ġejjin kienu rapportati fl-esperjenza ta' wara t-tqegħid fis-suq:
English: At therapeutic doses, no clinically significant interactions have been demonstrated with alcohol (for a blood alcohol level of 0.5 g/l).
Maltese: Ma kienx hemm effett klinikament sinifikanti f'dożi terapewtiċi flimkien ma' l-alkoħol (livell ta' alkoħol fid-demm ta' 0.5 g/l).
English: At therapeutic doses, no clinically significant interactions have been demonstrated with alcohol (for a blood alcohol level of 0.5 g/L).
Maltese: Ma kienx hemm effett klinikament sinifikanti f'dożi terapewtiċi flimkien ma' l-alkoħol (livell ta' alkoħol fid-demm ta' 0.5 g/L).
English: This medicine is available without prescription.
Maltese: Madanakollu,it-teħid tal-mediċina għandu jitwaqqaf.
English: There is no known specific antidote to cetirizine.
Maltese: M'hemmx antidotu speċifiku għal cetirizine.
English: Children aged from 6 to 12 years: 5 mg twice daily (a half tablet twice daily).
Maltese: Tfal ta' bejn is-6 u t-12-il sena: 5 mg darbtejn kuljum (10 taqtiriet darbtejn kuljum).
English: Patients with moderate renal impairment had a 3-fold increase in half-life and 70 % decrease in clearance compared to healthy volunteers.
Maltese: Pazjenti b'indeboliment moderat tal-kliewi kellhom żieda ta' tliet darbiet aktar fil-half-life u tnaqqis ta' 70 % fil-clearance meta mqabbla ma' voluntiera normali.
English: What Zyrtec looks like and contents of the pack White, oblong, film-coated tablet, with breakline and Y-Y logo Pack with 1, 4, 5, 7, 10, 14, 15, 20, 21, 30, 40, 45, 50, 60, 90, or 100 tablets.
Maltese: Pakkett oriġinali b' 1, 4, 5, 7, 10, 14, 15, 20, 21, 30, 40, 45, 50, 60, 90, jew 100 pillola.
English: oral drops, solution
Maltese: KAPLJICE, RAZTOPINA
English: Somnolence
Maltese: Maniġment
English: Adults and adolescents over 12 years of age: 10 mg once daily (1 tablet).
Maltese: Adulti u addoloxxenti ‘l fuq minn 12-il sena: 10 mg darba kuljum (pillola waħda).
English: Psychiatric disorders
Maltese: Mard psikjatriku
English: The MAH acknowledged that the indication section varies a lot from one Member State to the other but that the wording differences corresponded to three well-identified indications.
Maltese: Il-MAH irrikonoxxa li s-sezzjoni ta' l-indikazzjonijiet tvarja ħafna minn Stat Membru għal ieħor iżda li d-differenzi fil-formolazzjoni tal-kliem ikkorrispondew għal tliet indikazzjonijiet identifikati sew.
English: Austria: Zyrtec 10 mg/ml -Tropfen Belgium: Cetirizine-UCB, Zyrtec, Virlix Bulgaria: Zyrtec
Maltese: Cetirizine-UCB, Zyrtec, Virlix Il-Bulgarija:
English: rare: convulsions, movements disorders very rare: syncope, tremor, dysgeusia (altered taste)
Maltese: Rari: aċċessjonijiet, mard tal-moviment Rari ħafna: disġewsja, sinkope, rogħda, distonja, diskinesja
English: The MAH provided extensive testing data from the review of therapeutic trials and the corresponding clinical study reports in support of these indications and proposed the removal of the other indications such as atopic dermatitis, prevention of asthma, mosquito bites as the clinical evidences available to support these indications was considered insufficient.
Maltese: Il-MAH stqarr li l-proporzjon bejn il-benefiċċju u r-riskju kliniku ta' cetirizine ma ġiex evalwat speċifikament f'pazjenti b'insuffiċjenza renali u li għalhekk, id-doża hija bbażata fuq kalkoli farmakokinetiċi biss.
English: General disorders and administration site conditions: Uncommon: asthenia, malaise Rare: oedema
Maltese: Mhux komuni: astenja, telqa kbira, Rari: edima
English: Dosing adjustment is necessary in patients with moderate or severe renal impairment (see section 4.2).
Maltese: Hemm bżonn aġġustament fiddożaġġ f'pazjenti b'indeboliment moderat jew sever tal-kliewi(ara sezzjoni 4.2).
English: GRA (95% CI) Pain (95% CI) Urgency (95% CI)
Maltese: GRA (95 % CI) Uġigħ (95 % CI) Urġenza (95 % CI)
English: Tabulated summary of adverse events
Maltese: Lista tabulata ta' avvenimenti avversi
English: Consilient Health, Block 2A Richview Office Park, Clonskeagh, Dublin 14, D14 Y0A5 Ireland,
Maltese: Consilient Health, Block 2A Richview Office Park, Clonskeagh, Dublin 14, D14 Y0A5
English: PVC/Aclar-Aluminium blister with 90 (9x10) capsules.
Maltese: Folja tal-Aluminju PVC/Aclar b'90 (9x10) kapsula.
English: Increase of ≥ 20 cc (% pts)
Maltese: Żieda ta' ≥ 20 cc (% pti)
English: Inresa SAS, 1 rue Jean Monnet, F-68870 Bartenheim, France,
Maltese: Inresa SAS, 1 rue Jean Monnet, F-68870
English: BG, CZ, EE, EL, IS, IT, CY, LV, LT, HU, MT, PL, PT, RO, SK
Maltese: BG, CZ, EE, EL, IS, IT, CY, LV, LT, HU, MT, PL, PT, RO, SK bene-Arzneimittel GmbH, D-81479 Munich,
English: SIGMAPHARM Arzneimittel GmbH, Leystraße 129, A-1200 Wien, Österreich,
Maltese: SIGMAPHARM Arzneimittel GmbH, Leystraße 129, A-1200
English: • The other ingredients are microcrystalline cellulose, magnesium stearate, gelatin, titanium dioxide (E171).
Maltese: • L-eċċipjenti l-oħra huma ċelluloża mikrokristallina, stearat tal-manjeżju, ġelatina, diossidu tattitanju (E171).
English: 300 (3x100) hard capsules
Maltese: 300 (3x100) kapsula iebsa
English: • The active substance is pentosan polysulfate sodium.
Maltese: • Is-sustanza attiva hi pentosan polysulfate sodium.
English: 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 available data).
Maltese: 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: Infections, influenza
Maltese: Infezzjonijiet, influwenza
English: Uncommon Tinnitus
Maltese: Mhux komuni Tinnitus
English: Dr. Pfleger Arzneimittel GmbH, D-96045 Bamberg, Deutschland,
Maltese: Dr. Pfleger Arzneimittel GmbH, D-96045
English: Uncommon Severe Emotional Lability/Depression
Maltese: Mhux komuni Labbiltà Emottiva Severa/Dipressjoni
English: MEDICOPHARMACIA d.o.o., Pere Budmanija 5, 10000 Zagreb, Hrvatska,
Maltese: MEDICOPHARMACIA d.o.o., Pere Budmanija 5, 10000
English: Nocturia ns
Maltese: Nokturja ns
English: Anaemia, ecchymosis, haemorrhage, leukopenia, thrombocytopenia
Maltese: Anemija, ekimożi, emorraġija, lewkopenja, tromboċitopenja
English: Lamepro B.V., Burgemeester Guljélaan 2, NL-4837 CZ Breda, Pays-Bas, Nederland, Niederlande, Tél/Tel: +31 (0)76 5600030, lamepro@lamepro.nl
Maltese: Lamepro B.V., Burgemeester Guljélaan 2, NL-4837 CZ Breda, Pays-Bas, Nederland, Niederlande, Tél/Tel:
English: • infections, flu
Maltese: • infezzjonijiet, influwenza
English: BATCH NUMBER<, DONATION AND PRODUCT CODES>
Maltese: NUMRU TAL-LOTT <, DONAZZJONI U KODIĊI
English: Immune system disorder
Maltese: Disturbi fis-sistema immuni
English: Blister Do not store above 30°C.
Maltese: Taħżinx f'temperatura 'l fuq minn 30°C.