FrancophonIA/ELRC3.0 huggingface dataset:
English: MARKETING AUTHORIZATION HOLDER Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, L-Olanda.
English: MARKETING AUTHORISATION NUMBERS EU/1/96/007/008
Maltese: NUMRI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/96/007/008
English: How to store Humalog Mix50 KwikPen Before the first use store your Humalog Mix50 KwikPen in a refrigerator (2°C - 8°C).
Maltese: Kif taħżen Humalog Mix50 Qabel ma tuzah l-ewwel darba żomm Humalog Mix50 fi friġġ (2°C-8°C).
English: How to store Humalog Junior KwikPen Contents of the pack and other information
Maltese: Kif jidher Humalog KwikPen u l-kontenut tal-pakkett
English: This can be caused if:
Maltese: Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq:
English: BATCH NUMBER
Maltese: Tikketta talKarti
English: Telmisartan Teva Pharma EMA/14965/2015
Maltese: Telmisartan Teva PharmaEMA/14965/2015
English: It is available as tablets (20 mg, 40 mg and 80 mg).
Maltese: Jiġi f'għamla ta' pilloli (20 mg, 40 mg u 80 mg).
English: The full EPAR for Telmisartan Teva Pharma can be found on the Agency's website: EMA website/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: EMA website/Find medicine/Human medicines/European Public Assessment Reports.
English: Telmisartan Teva Pharma is a ‘generic medicine'.
Maltese: Telmisartan Teva Pharma huwa “mediċina ġenerika”.
English: For the treatment of essential hypertension, the usual recommended dose of Telmisartan Teva Pharma is 40 mg once a day, but some patients may benefit from using a 20-mg dose.
Maltese: Għall-kura ta' ipertensjoni essenzjali, id-doża rrakkomandata tas-soltu ta' Telmisartan Teva Pharma hija 40 mg darba kuljum, iżda xi pazjenti jistgħu jibbenefikaw mill-użu tad-doża ta' 20 mg.
English: This is a summary of the European Public Assessment Report (EPAR) for Telmisartan Teva Pharma.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Telmisartan Teva Pharma.
English: Telmisartan Teva Pharma is a medicine that contains the active substance telmisartan.
Maltese: Telmisartan Teva Pharma huwa mediċina li fiha s-sustanza attiva telmisartan.
English: Because Telmisartan Teva Pharma is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Micardis.
Maltese: Billi Telmisartan Teva Pharma huwa mediċina ġenerika, l-istudji fin-nies ġew limitati għal testitjiet li jistabbilixxu l-bijoekwivalenza tiegħu mal-mediċina ta' referenza Micardis.
English: The CHMP concluded that, in accordance with EU requirements, Telmisartan Teva Pharma has been shown to have comparable quality and to be bioequivalent to Micardis.
Maltese: Is-CHMP ikkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, intwera li Telmisartan Teva Pharma għandu kwalità kumparabbli u li huwa bijoekwivalenti għal Micardis.
English: This means that Telmisartan Teva Pharma is similar to a ‘reference medicine' already authorised in the European Union (EU) called Micardis.
Maltese: Dan ifisser li Telmisartan Teva Pharma huwa simili għall-“mediċina ta' referenza” diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem Micardis.
English: pressure is not reached, the dose can be increased to 80 mg, or another medicine for hypertension can be added, such as hydrochlorothiazide.
Maltese: pressjoni tad-demm mixtieqa ma tintlaħaqx, id-doża tista' tiżdied għal 80 mg, jew inkella tista' tiżdied mediċina oħra għall-ipertensjoni, bħal idroklorotiażid.
English: The European Commission granted a marketing authorisation valid throughout the EU for Telmisartan Teva Pharma on 3 October 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Telmisartan Teva Pharma fit-3 ta' Ottubru 2011.
English: What are the benefit and risk of Telmisartan Teva Pharma?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Telmisartan Teva Pharma?
English: Other information about Telmisartan Teva Pharma:
Maltese: Aktar tagħrif dwar Telmisartan Teva Pharma:
English: It also allows the heart to pump blood more easily, which can help to reduce the risk of future cardiovascular problems
Maltese: Dan jippermetti wkoll lil qalb tippompja d-demm b'mod aktar faċli, li jista' jgħin inaqqas irriskju ta' problemi kardjovaskolari futuri.
English: Because Telmisartan Teva Pharma is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Billi Telmisartan Teva Pharma huwa mediċina ġenerika u bijoekwivalenti għall-mediċina ta' referenza, tqies li l-benefiċċji u r-riskji huma l-istess bħal dawk tal-mediċina ta' referenza.
English: The active substance in Telmisartan Teva Pharma, telmisartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Maltese: Is-sustanza attiva f'Telmisartan Teva Pharma, it-telmisartan, hija tip ta' ‘antagonist tar-riċetturi talanġjotensina
English: What is Telmisartan Teva Pharma?
Maltese: Għal xiex jintuża Telmisartan Teva Pharma?
English: Telmisartan Teva Pharma is also used to prevent cardiovascular problems (problems with the heart and blood vessels) such as heart attacks or strokes.
Maltese: Telmisartan Teva Pharma jintuża wkoll għall-prevenzjoni ta' problemi kardjovaskulari (problemi talqalb u tal-vażijiet) bħal attakki tal-qalb jew puplesiji.
English: This allows the blood pressure to drop, reducing the risks associated with high blood pressure, such as having a heart attack or stroke.
Maltese: Dan iwassal għal tnaqqis fil-pressjoni taddemm u għal tnaqqis fir-riskji assoċjati mal-pressjoni għolja tad-demm, bħal attakk ta' qalb jew puplesija.
English: How is Telmisartan Teva Pharma used?
Maltese: Kif jintuża Telmisartan Teva Pharma?
English: Why has Telmisartan Teva Pharma been approved?
Maltese: Għaliex ġie approvat Telmisartan Teva Pharma?
English: The doctor should monitor the patient's blood pressure closely when starting Telmisartan Teva Pharma, and may decide to adjust the patient's blood pressure-lowering medication.
Maltese: Ittabib għandu josserva mill-qrib il-pressjoni tad-demm tal-pazjent meta jibda Telmisartan Teva Pharma, u jista' jiddeċiedi li jaġġusta l-pressjoni tad-demm tal-pazjent billi jnaqqas il-medikazzjoni.
English: Patients with mild or moderately reduced liver function should not receive doses higher than 40 mg a day
Maltese: Pazjenti bi tnaqqis moderat jew ħafif fil-funzjoni tal-fwied m'għandhomx jirċievu dożi ogħla minn 40 mg kuljum
English: Therefore, the CHMP's view was that, as for Micardis, the benefit outweighs the identified risk.
Maltese: Għaldaqstant il-fehma tas-CHMP kienet li, bħal fil-każ ta' Micardis, il-benefiċċji huma akbar mir-riskji identifikati.
English: “EXP”.
Maltese: “EXP”/“JIS”.
English: EU/1/07/414/001 7 tablets EU/1/07/414/002 14 tablets EU/1/07/414/003 28 tablets EU/1/07/414/004 30 tablets EU/1/07/414/005 56 tablets EU/1/07/414/006 60 tablets EU/1/07/414/007 90 tablets EU/1/07/414/008 112 tablets EU/1/07/414/009 180 tablets EU/1/07/414/010 336 tablets
Maltese: EU/1/07/414/001 7 pilloli EU/1/07/414/002 14-il pillola EU/1/07/414/003 28 pillola EU/1/07/414/004 30 pillola EU/1/07/414/005 56 pillola EU/1/07/414/006 60 pillola EU/1/07/414/007 90 pillola EU/1/07/414/008 112-il pillola EU/1/07/414/009 180 pillola EU/1/07/414/010
English: EU/1/07/414/001-010 EU/1/07/414/018
Maltese: EU/1/07/414/018
English: EU/1/07/414/018 336 tablets (3 packs of 112)
Maltese: EU/1/07/414/018 336 pillola (3 pakketti ta' 112)
English: Galvus 50 mg tablets
Maltese: Galvus 50 mg pilloli
English: Galvus 50 mg tablets vildagliptin
Maltese: Galvus 50 mg pilloli vildagliptin
English: Contains lactose (see leaflet for further information).
Maltese: Fih lactose (ara l-fuljett għal aktar informazzjoni).
English: Galvus 50 mg tablets are available in packs containing 7, 14, 28, 30, 56, 60, 90, 112, 180 or 336 tablets and in multipacks comprising 3 cartons, each containing 112 tablets.
Maltese: Galvus 50 mg pilloli jiġu f'pakketti li jkun fihom 7, 14, 28, 30, 56, 60, 90, 112, 180 jew 336 pillola u f'pakketti b'hafna li fihom 3 kartuni, li kull waħda minnhom fiha 112 pillola.
English: Date of first authorisation: 26 September 2007 Date of latest renewal: 23 July 2012
Maltese: Data tal-aħħar tiġdid: 23 Lulju 2012
English: Galvus is not a substitute for insulin in insulin-requiring patients.
Maltese: Galvus mhux sostitut ta' l-insulina f'pazjenti li jeħtieġu l-insulina.
English: Other medicines and Galvus
Maltese: Mediċini oħra u Galvus
English: The safety and efficacy of Galvus in children and adolescents (< 18 years) have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Galvus fi tfal u adolexxenti (< 18-il sena) ma ġewx determinati s'issa.
English: The active substance of Galvus, vildagliptin, belongs to a group of medicines called “oral antidiabetics”.
Maltese: Is-sustanza attiva ta' Galvus, vildagliptin, tagħmel parti minn grupp ta' mediċini li jissejħu “antidijabetiċi orali”.
English: Galvus contains lactose
Maltese: Galvus fih lactose
English: Galvus should not be used in patients with hepatic impairment, including patients with pre-treatment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3x the upper limit of normal (ULN) (see also sections 4.4 and 5.2).
Maltese: Galvus mgħandux jintuża f'pazjenti b'indeboliment tal-fwied, inklużi pazjenti li jkollhom alanine aminotransferase (ALT) jew aspartate aminotransferase (AST) qabel il-kura > 3 darbiet il-limitu ta' fuq tan-normal (ULN) (ara wkoll sezzjonijiet 4.4 u 5.2).
English: In the pioglitazone add-on study, the absolute weight increases with placebo, Galvus 100 mg daily were 1.4 and 2.7 kg, respectively.
Maltese: Fl-istudju biż-żieda ta' pioglitazone, il-piż assolut jiżdied bil-plaċebo u b'Galvus 100 mg kuljum kienu 1.4 u 2.7 kg rispettivament.
English: More than 5,000 male and more than 4,000 female patients received vildagliptin 50 mg once daily or 100 mg daily.
Maltese: Aktar minn 5,000 pazjent maskili u aktar minn 4,000 pazjenta femminili ngħataw vildagliptin 50 mg darba kuljum jew 100 mg kuljum.
English: Table 4 Adverse reactions reported in patients who received Galvus 100 mg daily as monotherapy in double-blind studies (N=1,855)
Maltese: Tabella 4 Reazzjonijiet avversi rrappurtati f'pazjenti li rċievew Galvus 100 mg kuljum bħala monoterapija fi studji double-blind (N=1,855)
English: Table 5 Adverse reactions reported in patients who received Galvus 50 mg twice daily in combination with metformin and a sulphonylurea (N=157)
Maltese: Reazzjonijiet avversi rapportati f'pazjenti li ħadu Galvus 50 mg darbtejn kuljum ma' metformin u xi sulphonylurea (N=157)
English: Adverse reactions reported in patients who received Galvus in double-blind studies as monotherapy and add-on therapies are listed below for each indication by system organ class and absolute frequency.
Maltese: Reazzjonijiet avversi rrappurtati f'pazjenti li rċievew Galvus fi studji double blind bħala monoterapija u terapiji miżjuda huma elenkati hawn taħt għall-kull indikazzjoni bil-klassi ta' l-organi tas-sistema u frekwenza assoluta.
English: More than 15,000 patients with type 2 diabetes participated in double-blind placebo- or activecontrolled clinical trials of up to more than 2 years' treatment duration.
Maltese: Aktar minn 15,000 pazjent b'dijabete tat-tip 2 ħadu sehem fi prova klinika double-blind kontrollati bi plaċebo jew attivi b'kura li damet għaddejja għal aktar minn sentejn.
English: Galvus contains lactose (milk sugar).
Maltese: 82 mg lactose (anidru).
English: Table 1 Adverse reactions reported in patients who received Galvus 100 mg daily in combination with metformin in double-blind studies (N=208)
Maltese: Tabella 1 Reazzjonijiet avversi rrappurtati f'pazjenti li rċievew Galvus 100 mg kuljum ma' metformin fi studji double-blind (N=208)
English: Table 3 Adverse reactions reported in patients who received Galvus 100 mg daily in combination with a thiazolidinedione in double-blind studies (N=158)
Maltese: Tabella 3 Reazzjonijiet avversi rrappurtati f'pazjenti li rċievew Galvus 100 mg flimkien ma' thiazolidinedione fi studji double-blind (N=158)
English: Table 6 Adverse reactions reported in patients who received Galvus 100 mg daily in combination with insulin (with or without metformin) in double-blind studies (N=371)
Maltese: Tabella 6 Reazzjonijiet avversi rapportati f'pazjenti li rċevew Galvus 100 mg kuljum f'kombinazzjoni mal-insuluna (bi jew mingħajr metformin) fi studji double blind (N=371)
English: Some patients have had the following side effects while taking Galvus alone:
Maltese: Xi pazjenti kellhom l-effetti sekondarji li ġejjin meta ħadu Galvus waħdu:
English: • Do not use any Galvus pack that is damaged or shows signs of tampering.
Maltese: • Tuża l-ebda pakkett ta' Galvus li jkun danneġġjat jew li juri sinjali ta' tbabis.
English: In patients with moderate or severe renal impairment or with end-stage renal disease (ESRD), the recommended dose of Galvus is 50 mg once daily (see also sections 4.4, 5.1 and 5.2).
Maltese: F'pazjenti b'indeboliment tal-kliewi moderat jew qawwi jew b'mard talkliewi fl-aħħar stadju (ESRD), id-doża rrakkomandata ta' Galvus hija ta' 50 mg darba kuljum (ara wkoll sezzjonijiet 4.4, 5.1 u 5.2).
English: Hepatitis (reversible upon discontinuation of the medicinal product) Abnormal liver function tests (reversible upon discontinuation of the medicinal product)
Maltese: Epatite (riversibbli mat-twaqqif tal-prodott mediċinali) Testijiet mhux normali tal-funzjoni tal-fwied (riversibbli mattwaqqif tal-prodott mediċinali) Disturbi muskolu-skeletriċi u tat-tessuti konnettivi
English: • Uncommon (may affect up to 1 in 100 people): Tiredness
Maltese: • Mhux komuni (jistgħu jaffettwaw sa persuna waħda minn kull 100):
English: Some patients have had the following side effects while taking Galvus, metformin and a sulphonylurea:
Maltese: Xi pazjenti kellhom l-effetti sekondarji li ġejjin waqt li kienu qed jieħdu Galvus, metformin u sulphonylurea:
English: Galvus is not recommended for use in children and adolescents (< 18 years).
Maltese: Galvus mhux irrakkomandat għall-użu fi tfal u adolexxenti (< 18-il sena).
English: Children and adolescents The use of Galvus in children and adolescents up to 18 years of age is not recommended.
Maltese: Tfal u adolexxenti L-użu ta' Galvus fi tfal u adolexxenti ta' età ta' sa 18-il sena mhux rakkomandat.
English: What Galvus looks like and contents of the pack Galvus 50 mg tablets are round, white to light yellowish and flat, with “NVR” on one side and “FB” on the other.
Maltese: Galvus 50 mg pilloli huma tondi, bojod jagħtu fl-isfar ċar u ċatti, b'“NVR” fuq naħa u “FB” fuq loħra.
English: Excipients
Maltese: Urtikarja
English: Your doctor may wish to alter your dose of Galvus if you are taking other medicines such as: - thiazides or other diuretics (also called water tablets) - corticosteroids (generally used to treat inflammation) - thyroid medicines - certain medicines affecting the nervous system.
Maltese: Jista' jkun li t-tabib tiegħek ikun jixtieq jibdillek id-doża tiegħek ta' Galvus jekk qed tieħu mediċini oħrajn bħal: - thiazides jew dijuretiċi oħrajn (imsejħa wkoll pilloli tal-awrina) - kortikosterojdi (ġeneralment użati biex jikkuraw l-infjammazzjoni) - mediċini għat-tirojde - ċerti mediċini li jeffettwaw is-sistema nervuża.
English: • 100 mg daily taken as 50 mg in the morning and 50 mg in the evening if you are taking Galvus alone, with another medicine called metformin or a glitazone, with a combination of metformin and a sulphonylurea, or with insulin.
Maltese: • 100 mg kuljum li tittieħed bħala 50 mg filgħodu u 50 mg filgħaxija jekk qed tieħu Galvus waħdu, ma' mediċina oħra li tissejjaħ metformin jew xi glitazone, flimkien ma' metformin u xi sulphonylurea, jew mal-insulina.
English: How to store Galvus
Maltese: X'fih Galvus
English: • Very rare (may affect up to 1 in 10,000 people): Sore throat, runny nose
Maltese: • Anġjoedema (rari: tista' taffettwa sa persuna waħda minn kull 1,000):
English: Galvus works by making the pancreas produce more insulin and less glucagon.
Maltese: Galvus sabiex jiġi evitat livell baxx ta' glukosju fid-demm [ipogliċemija]).
English: PIPETTE
Maltese: PIPETTA
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 09/02/2017.
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizazzjoni: 09/02/2017
English: EU/2/16/204/001 (3 x 0.25 ml) EU/2/16/204/002 (6 x 0.25 ml) EU/2/16/204/003 (3 x 0.5 ml) EU/2/16/204/004 (6 x 0.5 ml) EU/2/16/204/005 (3 x 1 ml) EU/2/16/204/006 (6 x 1 ml)
Maltese: EU/2/16/204/001 (3 x 0.25 ml) EU/2/16/204/002 (6 x 0.25 ml) EU/2/16/204/003 (3 x 0.5 ml)
English: - Treatment of ear mites (Otodectes cynotis).
Maltese: - Trattament għal-mites tal-widnejn (Otodectes cynotis).
English: Nematodes: - Treatment of adult roundworms (Toxocara cati) and adult intestinal hookworms (Ancylostoma tubaeforme).
Maltese: - Trattament għal-roundworms adulti (Toxocara cati) u hookworms intestinali adulti (Ancylostoma tubaeforme).
English: Stronghold Plus 30 mg/5 mg (orange cap)
Maltese: Stronghold Plus 30 mg/5 mg (tap oranġjo)
English: Stronghold Plus 60 mg/10 mg (green cap)
Maltese: Stronghold Plus 60 mg/10 mg (tap aħdar)
English: >2.5-5 kg >5-10 kg selamectin/sarolaner
Maltese: ≤2.5 kg >2.5-5 kg >5-10 kg Selamektin/sarolaner
English: MARKETING AUTHORISATION NUMBER(S) EU/2/16/204/001-006
Maltese: EU/2/16/204/004
English: Following topical administration of the Stronghold Plus both selamectin and sarolaner are well absorbed with bioavailability mean values of 40.5% and 57.9%, respectively and distribute systemically.
Maltese: Wara amministrazzjoni topikali ta' Stronghold Plus kemm selamekti kif ukoll sarolaner jiġu assorbiti sew b'valuri medji ta' biodisponibilità ta' 40.5% u 57.9% rispettivament u jiġu ddistribwiti b'mod sistemiku.
English: Fleas and ticks
Maltese: PERJODU TA' TIŻMIM
English: Stronghold Plus spot-on solution for cats Stronghold Plus spot-on solution for cats Stronghold Plus spot-on solution for cats
Maltese: Stronghold Plus soluzzjoni spot-on
English: Stronghold Plus should be administered as a single spot-on (topical) application in accordance with the following table (corresponding to a minimum of 6 mg/kg selamectin and 1 mg/kg sarolaner).
Maltese: Stronghold Plus għandu jingħata bħala applikazzjoni spot-on (fuq il-ġilda) ta' doża waħda skont din ittabella (tikkorrispondi għal doża minima ta' 6 mg/kg selamektin u 1 mg/kg sarolaner).
English: None known.
Maltese: Nematodi:
English: Strength and number of pipettes to be administered Stronghold Plus 15 mg/2.5 mg (yellow cap)
Maltese: Saħħa u numru ta' pipetti li għandhom jiġu amministrati Stronghold Plus 15 mg/2.5 mg (tapp isfar)
English: PACKAGE LEAFLET Stronghold Plus 15 mg/2.5 mg spot-on solution for cats ≤2.5 kg Stronghold Plus 30 mg/5 mg spot-on solution for cats >2.5-5 kg Stronghold Plus 60 mg/10 mg spot-on solution for cats >5-10 kg
Maltese: Stronghold Plus 15 mg/2.5 mg soluzzjoni spot-on għall-qtates ≤ 2.5 kg Stronghold Plus 30 mg/5 mg soluzzjoni spot-on għall-qtates >2.5-5.0 kg Stronghold Plus 60 mg/10 mg soluzzjoni spot-on għall-qtates >5-10 kg
English: Appropriate combination of pipettes
Maltese: Kontenut tal-pipetta
English: The product is available in packs of three pipettes (all pipette sizes) and six pipettes (all pipette sizes) placed in cardboard boxes.
Maltese: Il-prodott jiġi f'pakketti ta' tlett pipetti (pipetti tad-daqsijiet kollha) u sitt pipetti (pipetti tad-daqsijiet kollha) poġġuti f'kaxxi tal-kartun.
English: BLISTER
Maltese: Ektoparassiti
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each unit dose (pipette) delivers: Active substances: Stronghold Plus spot-on solution
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U SUSTANZI
English: Marketing authorisation holder and manufacturer responsible for batch release: Zoetis Belgium SA
Maltese: Tużax dan il-prodott mediċinali veterinarju wara d-data ta' skadenza murija fuq il-folja wara
English: BELGIUM
Maltese: TAMMINISTRA
English: The veterinary medicinal product has immediate and persistent acaricidal effect for 5 weeks against Ixodes ricinus and Ixodes hexagonus, and 4 weeks against
Maltese: Il-prodott mediċinali veterinarju għandu attività qattiela immedjat u persistent kontra l-briegħed għal 5 ġimgħat f' infestazzjonijiet ġodda.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Zoetis Belgium SA
Maltese: Soluzzjoni ċara, bejn bla kulur u safranija
English: 1348 Louvain-la-Neuve
Maltese: GĦALL-ĦRUĠ TAL-LOTT
English: Use only according to the benefit-risk assessment by the prescribing veterinarian.
Maltese: Uża biss skont il-valutazzjoni tal-beneficċcċju u rriskju mill-veterinarju responsabbli.
English: Dermacentor reticulatus and Rhipicephalus sanguineus.
Maltese: Dawn l-effetti ma jaffettwawx is-sigurtà jew l-effikaċja talprodott mediċinali veterinarju.
English: EU Procedure number Invented name Strength Pharmaceutical Form
Maltese: Numru tal-Proċedura ta'l-EU Isem inventat Qawwa Għamla farmaċewtika
English: 60 tablets 90 tablets 120 tablets
Maltese: 60 pillola 90 pillola 120 pillola
English: Rash, melanonychia, alopecia
Maltese: Raxx, melanoniċija, alopeċja
English: Haemoglobin < 4.5 g/dl
Maltese: < 4.5 g/dl
English: EU/1/07/397/002 60 tablets EU/1/07/397/003 90 tablets EU/1/07/397/004 120 tablets
Maltese: EU/1/07/397/002 60 pillola EU/1/07/397/003 90 pillola EU/1/07/397/004 120 pillola
English: Thrombocytopenia (< 80 x 109/L), anaemia (haemoglobin < 4.5 g/dl)3
Maltese: Tromboċitopenija (< 80 x 109/L), anemija (emoglobina < 4.5 g/dl)3
English: Severe hepatic impairment (Child-Pugh classification C).
Maltese: Indeboliment serju fil-fwied (Klassifikazzjoni C f'Child-Pugħ).
English: DEMO ABEE Τηλ : +30 210 81 61 802
Maltese: Τηλ : +30 210 81 61 802
English: Delpharm Lille Z.I de Roubaix Est Rue de Toufflers 59390 Lys-Lez-Lannoy France
Maltese: Rue de Toufflers 59390 Lys-Lez-Lannoy
English: Detailed information on this medicine is available on the European Medicines Agency website http://www.ema.europa.eu/.
Maltese: Mediċini http://www.ema.europa.eu/.
English: Gastrointestinal disturbances, vomiting, gastrointestinal ulcer, severe hypomagnesaemia
Maltese: Disturbi gastrointestinali, rimettar, ulċera gastrointestinali,
English: Cytotoxic Addmedica
Maltese: Ċitotossiku Addmedica
English: Geriatric, gender, race
Maltese: Pazjenti anzjani, Sess, Razza
English: UNIQUE IDENTIFIER- 2D BARCODE
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D Barcode 2D li jkollu l-identifikatur uniku inkluż
English: Hydroxycarbamide at 30, 100 and 300 µM is not metabolised in vitro by cytochrome P450s of human liver microsomes.
Maltese: Hydroxycarbamide f'konċentrazzjoni ta' 30, 100 u 300 µM mhux metabolizzat in vitro miċċitokromju P450s tal-mikrosomi tal-fwied uman.
English: - The active substance is hydroxycarbamide.
Maltese: - Is-sustanza attiva hi hydroxycarbamide.
English: Impaired fertility has been observed in male rats (see section 5.3).
Maltese: Kienet osservata fertilità indebolita f'firien maskili (ara sezzjoni 5.3).
English: In an open single-dose study in adult patients with Sickle Cell Syndrome (Yan JH et al, 2005) the influence of renal function on pharmacokinetics of hydroxycarbamide was assessed.
Maltese: Fi studju miftuħ b'doża waħda f'pazjenti adulti bis-Sindromu tas-Sickle Cells (Yan JH et al, 2005), linfluwenza tal-funzjoni tal-kliewi fuq il-farmakokinetika ta' hydroxycarbamide ġiet studjata.
English: The total exposure up to 24 h post-dose is 124 mg*h/L in children and adolescents and 135 mg*h/L in adult patients.
Maltese: 124 mg*siegħa/L fi tfal u adolexxenti u 135 mg*siegħa/L f'pazjenti adulti.
English: - The other ingredients are sodium stearyl fumarate, silicified microcrystalline cellulose and basic butylated methacrylate copolymer.
Maltese: - Is-sustanzi l-oħra huma sodium stearyl fumarate, silicified microcrystalline cellulose u basic butylated methacrylate copolymer.
English: Severe renal impairment (creatinine clearance < 30 ml/min).
Maltese: Indeboliment serju fil-kliewi (eliminazzjoni tal-krejatinina ta' < 30 ml/min).
English: Weight gain5
Maltese: Żieda fil-piż5