FrancophonIA/ELRC3.0 huggingface dataset:
English: If hypokalaemia develops during hydrochlorothiazide therapy, Exforge HCT should be discontinued until stable correction of the potassium balance.
Maltese: Jekk l-ipokalimja tiżviluppa waqt it-terapija b'hydrochlorothiazide, Exforge HCT għandu jitwaqqaf sakemm ikun hemm stabilità korretta fil-bilanċ tal-potassju.
English: Exforge HCT 10 mg/320 mg/25 mg film-coated tablets
Maltese: Exforge HCT 10 mg/320 mg/25 mg pilloli miksijin b'rita
English: An increased risk of non-melanoma skin cancer (NMSC) [basal cell carcinoma (BCC) and squamous cell carcinoma (SCC)] with increasing cumulative dose of hydrochlorothiazide exposure has been observed in two epidemiological studies based on the Danish National Cancer Registry.
Maltese: Ġie osservat riskju akbar ta' kanċer tal-ġilda mhux melanoma (NMSC) [karċinoma ta' ċellola bażali (BCC) u karċinoma ta' ċellola skwamuża (SCC)] b'doża kumulattiva li tiżdied ta' esponiment għal hydrochlorothiazide fiż-żewġ studji epidemjoloġiċi bbażati fuq ir-Reġistru Nazzjonali tal-Kanċer tad-Danimarka.
English: In the controlled trial of Exforge HCT, the counteracting effects of valsartan 320 mg and hydrochlorothiazide 25 mg on serum potassium approximately balanced each other in many patients.
Maltese: Fil-prova kkontrollata ta' Exforge HCT, l-effetti kontra xulxin li valsartan 320 mg u hydrochlorthiazide 25 mg għandhom fuq il-potassju fis-serum bejn wieħed u ieħor ibbilanċjaw lillxulxin f'ħafna mill-pazjenti.
English: A cumulative dose-response relationship was demonstrated with an adjusted OR 2.1 (95% CI: 1.7-2.6) increasing to OR 3.9 (3.0-4.9) for high use (~25000 mg) and OR 7.7 (5.7-10.5) for the highest cumulative dose (~100000 mg) (see also section 4.4).
Maltese: Studju ieħor wera assoċjazzjoni possibbli bejn il-kanċer tax-xoffa (SCC) u l-esponiment għal hydrochlorothiazide: 633 każ ta' kanċer tax-xoffa tqabblu ma' 63,067 kontroll tal-popolazzjoni, bl-użu ta' strateġija ta' teħid ta' kampjuni b'riskju ssettjat Intweriet relazzjoni għar-rispons tad-doża kumulattiva b'OR aġġustata ta' 2.1 (95% CI: 1.7-2.6) li tiżdied għal OR 3.9 (3.0-4.9) għal użu kbir (~25,000 mg) u OR 7.7 (5.7-10.5) għall-ogħla doża kumulattiva (~100,000 mg) (ara wkoll is-sezzjoni 4.4).
English: Exforge HCT 10 mg/320 mg/25 mg film-coated tablets The active substances of Exforge HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Maltese: Exforge HCT 10 mg/320 mg/25 mg pilloli miksijin b'rita Is-sustanzi attivi ta' Exforge HCT huma amlodipine (bħala amlodipine besylate), valsartan u hydrochlorthiazide.
English: In the 8-week controlled clinical study, changes in laboratory parameters observed with the combination of Exforge HCT were minor and consistent with the pharmacological mechanism of action of the monotherapy agents.
Maltese: Fl-istudju kliniku kkontrollat ta' 8 ġimgħat, it-tibdiliet fil-parametri tal-laboratorju osservati bit-taħlita ta' Exforge HCT kienu żgħar u konsistenti mal-mekkaniżmu farmakoloġiku ta' azzjoni tas-sustanzi meta jingħataw waħedhom.
English: Exforge HCT 10 mg/320 mg/25 mg film-coated tablets are brown-yellow, oval tablets with “NVR” on one side and “VFL” on the other side.
Maltese: Exforge HCT 10 mg/320 mg/25 mg pilloli miksijin b'rita huma pilloli kannella fl-isfar, ovali b'“NVR” fuq naħa waħda u b'“VFL” fuq in-naħa l-oħra.
English: Exforge HCT 5 mg/160 mg/25 mg film-coated tablets are yellow, oval tablets with “NVR” on one side and “VEL” on the other side.
Maltese: Exforge HCT 5 mg/160 mg/25 mg pilloli miksijin b'rita pilloli sofor, ovali b'“NVR” fuq naħa waħda u b'“VEL” fuq in-naħa l-oħra.
English: Exforge HCT was studied in a double-blind, active controlled study in hypertensive patients.
Maltese: Exforge HCT kien studjat fi studju double-blind ikkontrollat b'mod attiv f'pazjenti bi pressjoni għolja.
English: Exforge HCT 10 mg/320 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide
Maltese: Exforge HCT 10 mg/320 mg/25 mg pilloli miksijin b'rita amlodipine/valsartan/hydrochlorothiaziade
English: Caution is advised in patients with heart failure and coronary artery disease, particularly at the maximum dose of Exforge HCT, 10 mg/320 mg/25 mg.
Maltese: Hija rrakkomandata kawtela f'pazjenti b'insuffiċjenza tal-qalb u b'mard tal-arterji koronarji, b'mod partikulari meta tingħata logħla doża ta' Exforge HCT, 10 mg/320 mg/25 mg.
English: Exforge HCT 10 mg/160 mg/12.5 mg film-coated tablets are pale yellow, oval tablets with “NVR” on one side and “VDL” on the other side.
Maltese: Exforge HCT 10 mg/160 mg/12.5 mg pilloli miksijin b'rita huma pilloli sofor ċari, ovali b'“NVR” fuq naħa waħda u b'“VDL” fuq in-naħa l-oħra.
English: Exforge HCT 10 mg/160 mg/25 mg film-coated tablets are brown-yellow, oval tablets with “NVR” on one side and “VHL” on the other side.
Maltese: Exforge HCT 10 mg/160 mg/25 mg pilloli miksijin b'rita huma pilloli kannella fl-isfar, ovali b'“NVR” fuq naħa waħda u b'“VHL” fuq in-naħa l-oħra.
English: Exforge HCT 5 mg/160 mg/12.5 mg film-coated tablets The active substances of Exforge HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Maltese: Exforge HCT 5 mg/160 mg/12.5 mg pilloli miksijin b'rita Is-sustanzi attivi ta' Exforge HCT huma amlodipine (bħala amlodipine besylate), valsartan u hydrochlorthiazide.
English: Exforge HCT 10 mg/160 mg/12.5 mg film-coated tablets The active substances of Exforge HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Maltese: Exforge HCT 10 mg/160 mg/12.5 mg pilloli miksijin b'rita Is-sustanzi attivi ta' Exforge HCT huma amlodipine (bħala amlodipine besylate), valsartan u hydrochlorthiazide.
English: In patients with mild to moderate hepatic impairment without cholestasis, the maximum recommended dose is 80 mg valsartan, and therefore, Exforge HCT is not suitable in this group of patients (see sections 4.2, 4.3 and 5.2).
Maltese: F'pazjenti b'indeboliment tal-fwied minn ħafif sa moderat mingħajr kolestażi, l-ogħla doża rrakkomandata hija ta' 80 mg valsarta, u għaldaqstant, Exforge HCT mhuwiex addattat għal dan il-grupp ta' pazjenti (ara sezzjonijiet 4.2, 4.3 u 5.2).
English: Exforge HCT 5 mg/160 mg/25 mg film-coated tablets The active substances of Exforge HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Maltese: Exforge HCT 5 mg/160 mg/25 mg pilloli miksijin b'rita Is-sustanzi attivi ta' Exforge HCT huma amlodipine (bħala amlodipine besylate), valsartan u hydrochlorthiazide.
English: Exforge HCT 5 mg/160 mg/25 mg film-coated tablets
Maltese: Exforge HCT 5 mg/160 mg/25 mg pilloli miksijin b'rita
English: The safety of Exforge HCT has been evaluated at its maximum dose of 10 mg/320 mg/25 mg in one controlled short-term (8 weeks) clinical study with 2,271 patients, 582 of whom received valsartan in combination with amlodipine and hydrochlorothiazide.
Maltese: Is-sigurtà ta' Exforge HCT ġiet evalwata bl-ogħla doża ta' 10 mg/320 mg/25 mg fi studju kliniku wieħed ikkontrollat li sar fuq perjodu qasir ta' żmien (8 ġimgħat) b'2,271 pazjent, li minnhom 582 irċevew valsartan flimkien ma' amlodipine u hydrochlorthiazide.
English: The other ingredients are cellulose microcrystalline; crospovidone (type A); silica, colloidal anhydrous; magnesium stearate; hypromellose (substitution type 2910 (3 mPa.s)), macrogol 4000, talc, titanium dioxide (E171).
Maltese: Is-sustanzi l-oħra huma ċelluloża mikrokristallina; krospovidon (tip A); silica, colloidal anhydrous; stearat tal-manjesju; ipromelloża (sostituzzjoni tip 2910 (3 mPa.s)), makrogol 4000, talc, dijossidu tattitanju (E171).
English: Exforge HCT 10 mg/160 mg/25 mg film-coated tablets The active substances of Exforge HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Maltese: Exforge HCT 10 mg/160 mg/25 mg pilloli miksijin b'rita Is-sustanzi attivi ta' Exforge HCT huma amlodipine (bħala amlodipine besylate), valsartan u hydrochlorthiazide.
English: Exforge HCT 10 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide
Maltese: Exforge HCT 10 mg/160 mg/25 mg pilloli miksijin b'rita amlodipine/valsartan/hydrochlorothiaziade
English: The other ingredients are cellulose microcrystalline; crospovidone (type A); silica, colloidal anhydrous; magnesium stearate; hypromellose (substitution type 2910 (3 mPa.s)), macrogol 4000, talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).
Maltese: Is-sustanzi l-oħra huma ċelluloża mikrokristallina; krospovidon (tip A); silica, colloidal anhydrous; stearat tal-manjesju; ipromelloża (sostituzzjoni tip 2910 (3 mPa.s)), makrogol 4000, talc, dijossidu tattitanju (E171), ossidu tal-ħadid isfar (E172), ossidu tal-ħadid aħmar (E172).
English: Exforge HCT 5 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide
Maltese: Exforge HCT 5 mg/160 mg/25 mg pilloli miksijin b'rita amlodipine/valsartan/hydrochlorothiaziade
English: EU/1/09/569/048 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/569/047 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Maltese: EU/1/09/569/048 280 pillola miksija b'rita (pakkett multiplu, 20 kartuna b'14-il pillola) EU/1/09/569/047 280 pillola miksija b'rita (pakkett multiplu, 4 kartuniet b'70 pillola) (doża waħda)
English: EU/1/09/569/036 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/569/035 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Maltese: EU/1/09/569/036 280 pillola miksija b'rita (pakkett multiplu, 20 kartuna b'14-il pillola) EU/1/09/569/035 280 pillola miksija b'rita (pakkett multiplu, 4 kartuniet b'70 pillola) (doża waħda)
English: Exforge HCT 10 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide
Maltese: Exforge HCT 10 mg/160 mg/12.5 mg pilloli miksijin b'rita amlodipine/valsartan/hydrochlorothiaziade
English: The other ingredients are cellulose microcrystalline; crospovidone (type A); silica, colloidal anhydrous, magnesium stearate, hypromellose (substitution type 2910 (3 mPa.s)), macrogol 4000, talc, yellow iron oxide (E172).
Maltese: Is-sustanzi l-oħra huma ċelluloża mikrokristallina; krospovidon (tip A); silica, colloidal anhydrous, stearat tal-manjesju, ipromelloża (sostituzzjoni tip 2910 (3 mPa.s)), makrogol 4000, talc, ossidu talħadid isfar (E172).
English: When Exforge HCT is used in patients with renal impairment periodic monitoring of serum electrolytes (including potassium), creatinine and uric acid serum levels is recommended.
Maltese: Meta Exforge HCT jintuża f'pazjenti b'indeboliment renali huwa rrakkomandat li jsir monitoraġġ minn żmien għal żmien tal-elettroliti tas-serum (inkluż il-livelli tal-potassju), tal-kreatinina u tal-aċidu uriku fis-serum.
English: Exforge HCT 10 mg/320 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Maltese: TAL-PRODOTT MEDIĊINALI Exforge HCT 10 mg/320 mg/25 mg pilloli miksijin b'rita amlodipine/valsartan/hydrochlorthiazide
English: Exforge HCT 5 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide
Maltese: Exforge HCT 5 mg/160 mg/12.5 mg pilloli miksijin b'rita amlodipine/valsartan/hydrochlorothiaziade
English: Exforge HCT 10 mg/160 mg/25 mg film-coated tablets
Maltese: Exforge HCT 10 mg/160 mg/25 mg pilloli miksijin b'rita
English: The other ingredients are cellulose microcrystalline; crospovidone (type A); silica, colloidal anhydrous, magnesium stearate, hypromellose (substitution type 2910 (3 mPa.s)), macrogol 4000, talc, titanium dioxide (E171), yellow iron oxide (E172).
Maltese: Is-sustanzi l-oħra huma ċelluloża mikrokristallina; krospovidon (tip A); silica, colloidal anhydrous, stearat tal-manjesju, ipromelloża (sostituzzjoni tip 2910 (3 mPa.s)), makrogol 4000, talc, dijossidu tattitanju (E171), ossidu tal-ħadid isfar (E172).
English: EU/1/09/569/012 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/569/011 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Maltese: EU/1/09/569/012 280 pillola miksija b'rita (pakkett multiplu, 20 kartuna b'14-il pillola) EU/1/09/569/011 280 pillola miksija b'rita (pakkett multiplu, 4 kartuniet b'70 pillola) (doża waħda)
English: EU/1/09/569/060 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/569/059 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Maltese: EU/1/09/569/060 280 pillola miksija b'rita (pakkett multiplu, 20 kartuna b'14-il pillola) EU/1/09/569/059 280 pillola miksija b'rita (pakkett multiplu, 4 kartuniet b'70 pillola) (doża waħda)
English: EU/1/09/569/024 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/569/023 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Maltese: EU/1/09/569/024 280 pillola miksija b'rita (pakkett multiplu, 20 kartuna b'14-il pillola) EU/1/09/569/023 280 pillola miksija b'rita (pakkett multiplu, 4 kartuniet b'70 pillola) (doża waħda)
English: Exforge HCT 5 mg/160 mg/12.5 mg film-coated tablets
Maltese: Exforge HCT 5 mg/160 mg/12.5 mg pilloli miksijin b'rita
English: What Exforge HCT looks like and contents of the pack Exforge HCT 5 mg/160 mg/12.5 mg film-coated tablets are white, oval tablets with “NVR” on one side and “VCL” on the other side.
Maltese: Kif jidher Exforge HCT u l-kontenut tal-pakkett Exforge HCT 5 mg/160 mg/12.5 mg pilloli miksijin b'rita huma pilloli bojod, ovali b'“NVR” fuq naħa waħda u b'“VCL” fuq in-naħa l-oħra.
English: This is a disease in which the adrenal glands make too much of the hormone aldosterone If this applies to you, the use of Exforge HCT is not recommended.
Maltese: Jekk aċċidentalment ħadt wisq pilloli ta' Exforge HCT, kellem tabib immedjatament.
English: Exforge HCT individual component
Maltese: Komponent individwali ta' Exforge HCT
English: EU/1/09/569/044 56 x 1 film-coated tablet (unit dose) EU/1/09/569/045 98 x 1 film-coated tablet (unit dose) EU/1/09/569/046 280 x 1 film-coated tablet (unit dose)
Maltese: EU/1/09/569/037 14-il pillola miksija b'rita EU/1/09/569/038 28 pillola miksija b'rita EU/1/09/569/039 30 pillola miksija b'rita EU/1/09/569/040 56 pillola miksija b'rita EU/1/09/569/041 90 pillola miksija b'rita EU/1/09/569/042 98 pillola miksija b'rita EU/1/09/569/043 280 pillola miksija b'rita EU/1/09/569/044 56 x pillola 1 miksija b'rita (doża waħda)
English: Exforge HCT 10 mg/160 mg/12.5 mg film-coated tablets
Maltese: Exforge HCT 10 mg/160 mg/12.5 mg pilloli miksijin b'rita
English: Exforge HCT can be used by people aged 65 years and over at the same dose as for other adults and in the same way as they have already taken the three substances called amlodipine, valsartan and hydrochlorothiazide.
Maltese: Exforge HCT jista' jintuża minn persuni li għandhom 65 sena u aktar fl-istess doża bħal dik ta' adulti oħra u bl-istess mod kif ħadu diġà t-tliet sustanzi msejħa amlodipine, valsartan u hydrochlorthiazide.
English: Exforge HCT 5 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Maltese: TAL-PRODOTT MEDIĊINALI Exforge HCT 5 mg/160 mg/25 mg pilloli miksijin b'rita amlodipine/valsartan/hydrochlorthiazide
English: Other medicines and Exforge HCT
Maltese: Mediċini oħra u Exforge HCT
English: EU/1/09/569/006 98 film-coated tablets
Maltese: EU/1/09/569/009 98 x pillola 1 miksija b'rita (doża waħda)
English: How to take Exforge HCT
Maltese: X'fih Exforge HCT
English: The maximum recommended dose of Exforge HCT is 10 mg/320 mg/25 mg.
Maltese: L-ogħla doża rrakkomandata ta' Exforge HCT hija ta' 10 mg/320 mg/25 mg.
English: EU/1/09/569/056 56 x 1 film-coated tablet (unit dose) EU/1/09/569/057 98 x 1 film-coated tablet (unit dose) EU/1/09/569/058 280 x 1 film-coated tablet (unit dose)
Maltese: EU/1/09/569/025 14-il pillola miksija b'rita EU/1/09/569/026 28 pillola miksija b'rita EU/1/09/569/027 30 pillola miksija b'rita EU/1/09/569/028 56 pillola miksija b'rita EU/1/09/569/029 90 pillola miksija b'rita EU/1/09/569/030 98 pillola miksija b'rita EU/1/09/569/031 280 pillola miksija b'rita EU/1/09/569/032 56 x pillola 1 miksija b'rita (doża waħda)
English: MedDRA system organ class
Maltese: Sistema tal-klassifika talorgani MedDRA
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1290/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/18/1290/001
English: Elms Industrial Estate
Maltese: Elms Industrial Estate Bedford
English: Data from a study used as a historical control (van Spronsen et al., 1994) showed the following survival probability.
Maltese: Dejta minn studju użata bħala kontroll storiku (van Spronsen et al., 1994) uriet il-probabbiltà ta' sopravivenza li ġejja.
English: Thrombocytopenia, leucopenia, granulocytopenia
Maltese: Tromboċitopenja, lewkopenja, granuloċitopenija
English: Probability of no HCC (95% confidence interval) at Start 2 years 4 years 6 years 2 years
Maltese: Probabbiltà ta' ebda HCC (intervall ta' kunfidenza ta' 95%) wara bidu sentejn 4 snin 6 snin sentejn 4 snin
English: Frequency is defined as 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).
Maltese: Ilfrekwenza hija definita bħala 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: Marketing Authorisation Holder Cycle Pharmaceuticals (Europe) Limited 70 Sir John Rogerson's Quay Dublin 2
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Cycle Pharmaceuticals (Europe) Limited 70 Sir John Rogerson's Quay Dublin 2
English: Name and address of the manufacturer(s) responsible for batch release Central Pharma (Contract Packing) Limited Caxton Road
Maltese: Central Pharma (Contract Packing) Limited Caxton Road
English: Based on in vitro studies, nitisinone is not expected to inhibit CYP 1A2, 2C9, 2C19, 2D6, 2E1 or 3A4mediated metabolism.
Maltese: Ibbażat fuq studji in vitro, nitisinone mhux mistenni li jinibixxi metaboliżmu medjat ta' CYP 1A2, 2C9, 2C19, 2D6, 2E1 jew 3A4.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26 July 2018
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 26 ta' Lulju 2018
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, Various alimentary tract and metabolism products, ATC code: A16AX04.
Maltese: Prodotti oħrajn tal-passaġġ alimentari u tal-metaboliżmu, Prodotti varji tal-passaġġ alimentari u tal-metaboliżmu, Kodiċi ATC: A16A X04.
English: Each bottle contains 60 tablets.
Maltese: Kull flixkun fih 60 pillola.
English: INFORMATION IN BRAILLE Nityr 10 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Nityr 10 mg
English: The clearance and half-life were determined to be 0.0956 l/kg body weight/day and 52.1 hours respectively.
Maltese: Ittneħħija u l-half-life ġew stabbiliti li huma 0.0956 Litri /kg ta' piż tal-ġisem / kuljum u 52.1 sigħat rispettivament.
English: Conjunctivitis, corneal opacity, keratitis, photophobia, eye pain
Maltese: Konġuntivite, opaċità talkornea, keratite, fotofobija, uġigħ fl-għajnejn
English: A population pharmacokinetic analysis has been conducted on a group of 207 HT-1 patients.
Maltese: L-analiżi farmakokinetika tal-popolazzjoni twettqet fuq grupp ta' 207 pazjenti li kellhom l-HT-1.
English: In 23 healthy volunteers, after administration of a single dose of Nityr tablets (10 mg) the terminal half-life (median) of nitisinone in plasma was 59 hours (ranging from 41 to 74 hours).
Maltese: Fi 23 volontier f'saħħtu, wara l-għoti ta' doża waħda tal-pilloli Nityr (10 mg) il-half-life terminali (medjan) ta' nitisinone fil-plażma kien ta' 59 siegħa (ivarja minn 41 għal 74 siegħa).
English: Nityr contains lactose
Maltese: Nityr fih lactose
English: Breastfeeding (see sections 4.6 and 5.3).
Maltese: Ommijiet li jkunu qed jużaw nitisinone m'għandhomx ireddgħu (ara sezzjonijiet 4.6 u 5.3).
English: Nitisinone treatment leads to normalised porphyrin metabolism with normal erythrocyte porphobilinogen synthase activity and urine 5-aminolevulinate, decreased urinary excretion of succinylacetone, increased plasma tyrosine concentration and increased urinary excretion of phenolic acids.
Maltese: Il-kura b'nitisinone twassal għal metaboliżmu normalizzat ta' porphyrin bl-attività ta' erythrocyte synthase ta' porphobilinogen normali u 5 aminolevulinate fl-awrina, tnaqqis fit-tneħħija fl-awrina ta' succinylacetone, żieda fil- konċentrazzjoni ta' tyrosine fil-plażma u żieda fit-tneħħija fl-awrina talphenolic acids.
English: Each tablet contains less than 120 mg of lactose (as monohydrate).
Maltese: Kull pillola fiha inqas minn 120 mg ta' lattożju (bħala monoidrat).
English: Start age ≤ 24 months Start age > 24 months
Maltese: Il-pazjenti kollha Età fil-bidu ≤ 24 xahar Età fil-bidu > 24 xahar
English: White to beige, round (7 x 2.3 mm), flat tablets which may display light yellow to brown speckles, marked “10” on one side and “L” on the other side.
Maltese: Pilloli ċatti bojod fil-beġ, tondi (7 x 2.3 mm), li jista' jkollhom tikek sofor ċari jew kannelli, immarkati“10” fuq naħa u “L” fuq in-naħa l-oħra.
English: The active ingredient of Nityr is nitisinone.
Maltese: Is-sustanza attiva ta' Nityr hija nitisinone.
English: Lactose monohydrate
Maltese: Lattożju monoidrat
English: Available data from a clinical study indicates that in more than 90% of the patients urine succinylacetone was normalised during the first week of treatment.
Maltese: Dejta disponibbli minn studju kliniku tindika li iktar minn 90% ta' succinylacetone flawrina tal-pazjenti kien normalizzat matul l-ewwel ġimgħa tal-kura.
English: NAME OF THE MEDICINAL PRODUCT Nityr 10 mg tablets nitisinone
Maltese: Pilloli Nityr 10 mg nitisinone
English: It is recommended to also monitor serum alpha-fetoprotein concentrations.
Maltese: Hu rakkomandat ukoll li jsir monitoraġġ tal-konċentrazzjonijiet ta' alpha-fetoprotein fis-serum.
English: A pre- and postnatal development study in the mouse showed statistically significantly reduced pup survival and pup growth during the weaning period at dose levels 125- and 25-fold higher, respectively, then the maximum recommended human dose, with a trend toward a negative effect on pup survival starting from the dose of 5 mg/kg/day.
Maltese: Studju dwar l-iżvilupp ta' qabel u wara t-twelid fil-ġrieden wera sopravivenza u t-tkabbir tal-frieħ matul il-perjodu tal-ftim, li kienu mnaqqsa b'mod statistikament sinifikanti f'livelli ta' doża 125 u 25 darba ogħla, rispettivament, mid-doża massima rakkomandata fil-bniedem, b'tendenza lejn effett negattiv tas-sopravivenza tal-frieħ li jibda mid-doża ta' 5 mg/kg/kuljum.
English: In the rabbit, nitisinone induced a dose-related increase in malformations (umbilical hernia and gastroschisis) from a dose level 2.5-fold higher than the maximum recommended human dose (2 mg/kg/day).
Maltese: Fil-fniek, nitisinone ikkaġuna żieda fil-malformazzjonijiet relatati mad-doża (ernja umbilikali u gastroskiżi) minn livell ta' doża 2.5 darbiet ogħla mill-massimu rakkomandat fil-bniedem (2 mg/kg/kuljum).
English: - Each tablet contains 10 mg nitisinone.
Maltese: - Kull pillola fiha 10 mg nitisinone.
English: Other medicines and Nityr
Maltese: Mediċini oħra u Nityr
English: Nitisinone is metabolised in vitro by CYP 3A4 and dose-adjustment may therefore be needed when nitisinone is co-administered with inhibitors or inducers of this enzyme.
Maltese: Nitisinone jiġi metabolizzat in vitro minn CYP 3A4 u jista' jkun hemm bżonn ta' aġġustament taddoża meta nitisinone jingħata flimkien ma' inibituri jew inducers ta' din l-enzima.
English: The recommended initial dose in the paediatric and adult population is 1 mg/kg body weight administered orally.
Maltese: Id-doża tal-bidu rakkomandata fil-popolazzjoni pedjatrika u adulta hi ta' 1 mg/kg ta' piż tal-ġisem li jingħataw mill-ħalq.
English: Contains lactose
Maltese: U LUŻU
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti li jsofru minn problemi ereditarji rari ta' intolleranza tal-galattożju, defiċjenza totali ta' lattożju jew assorbiment ħażin ta' glukożju-galattożju ma għandhomx jieħdu dal-prodott mediċinali.