FrancophonIA/ELRC3.0 huggingface dataset:
English: Hemiparesis, aphasia, balance impaired, somnolence, confusion, dizziness, memory impairment, concentration impaired, dysphasia, neurological disorder (NOS), neuropathy, peripheral neuropathy, paresthesia, speech disorder, tremor
Maltese: Emipareżi, afażja, telf talekwilibriju, ngħas, konfużjoni, sturdament, telf tal-memorja, telf tal- konċentrazzjoni, disfażja, disturbi newroloġiċi (NOS), newropatija, newropatija periferali, parasteżija, diffikulta`biex ilissnu, tregħid
English: TMZ administration can be continued throughout the 42 day concomitant period (up to 49 days) if all of the following conditions are met:
Maltese: L-għoti ta' TMZ jista' jitkompla fil-perijodu ta' 42 jum meta jkunu qed jingħataw flimkien (sa 49 jum) jekk ilkundizzjonijiet kollha li ġejjin ikunu sodisfaċenti:
English: Clinical trial experience
Maltese: Esperjenza mill-provi kliniċi
English: Temozolomide Accord 250 mg hard capsules have a white body, a white cap, and are imprinted ‘TMZ' on cap and ‘250' on body with black ink.
Maltese: Temozolomide Accord 250 mg kapsuli ibsin għandhom korp abjad, ras bajda u fuqhom hemm stampat b'linka sewda ‘TMZ' fuq ir-ras u ‘250' fuq il-korp.
English: Newly diagnosed glioblastoma multiforme
Maltese: GĦAMLA KWALITATTIVA
English: The cytotoxicity of MTIC is thought to be due primarily to alkylation at the O6 position of guanine with additional alkylation also occurring at the N7 position.
Maltese: Huwa maħsub li ċ-ċitotossiċità ta' monomethyl triazenoimidazole carboxamide (MTIC) hija primarjament minħabba l-alkylation f'pożizzjoni O6 ta' guanine, b'alkylation addizzjonali li sseħħ ukoll f'pożizzjoni N7.
English: Otitis media, tinnitus, hyperacusis, earache
Maltese: Otitis media, tisfir fil-widnejn, iperakusi, uġigħ fil-widnejn
English: CTC Grade 4b a : TMZ dose levels are listed in Table 2. b : TMZ is to be discontinued if:
Maltese: CTC Grad 3 CTC Grad 4b a:
English: Male fertility
Maltese: Ċitotossiku
English: Deafness, vertigo, earache
Maltese: Telf tas-smigħ, vertigo, uġigħ fil-widnejn
English: Temozolomide Accord 100 mg hard capsules: gelatine, titanium dioxide (E 171), red iron oxide (E 172), water.
Maltese: Temozolomide Accord 100 mg kapsuli ibsin: gelatine, titanium dioxide (E171) u red iron oxide (E172), ilma.
English: The primary targets of toxicity included the bone marrow, lymphoreticular system, testes, the gastrointestinal tract and, at higher doses, which were lethal to 60% to 100% of rats and dogs tested, degeneration of the retina occurred.
Maltese: Il-miri ewlenin tat-tossiċità kienu jinkludu l-mudullun, is-sistema limforetikulari, it-testikoli u l-apparat gastrointestinali u, f'dożi aktar qawwija, li kkaġunaw il-mewt lil 60 % sa 100 % tal-firien u l-klieb ittestjati, kien hemm deġenerazzjoni tarretina.
English: Take your prescribed dose of Temozolomide Accord once a day.
Maltese: Ħu d-doża preskritta ta' Temozolomide Accord darba kuljum.
English: • abnormal or blurred vision, double-vision
Maltese: • vista anormali jew mċajpra, vista doppja
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING SACHET CARTON
Maltese: Aħżen fil-pakkett oriġinali sabiex tilqa' mill-umdità.
English: Dry skin, pruritus
Maltese: Limfopenija, petekje
English: Cases of myelodysplastic syndrome and secondary malignancies, including myeloid leukaemia, have also been reported very rarely (see section 4.8).
Maltese: Każijiet ta' sindrome majelodisplastika u malinni sekondarji, li jinkludu lewkimija majelojde kienu rrappurtati b'mod rari ħafna (ara sezzjoni 4.8).
English: Type III amber glass bottles with polypropylene child-resistant closures and a desiccant, containing 5 or 20 capsules.
Maltese: Fliexken tal-ħġieġ ambra ta' Tip III b'tappijiet tal-polypropylene reżistenti għal ftuħ u b'dessikanti, li fihom 5 jew 20 kapsula.
English: Monotherapy phase
Maltese: Fażi ta' Monoterapija
English: • bloated stomach, difficulty controlling your bowel movements, haemorrhoids (piles)
Maltese: • stonku minfuħ, diffikultà biex tikkontrolla l-movimenti ta' imsarnek, emorrojdi (murliti)
English: Temozolomide Accord is administered in combination with focal radiotherapy (concomitant phase) followed by up to 6 cycles of temozolomide (TMZ) monotherapy (monotherapy phase).
Maltese: Temozolomide Accord jingħata flimkien ma' radjuterapija fokali (fażi konkomitanti) segwit b'mhux aktar minn 6 ċikli ta'monoterapija b'temozolomide (TMZ) (fażi ta' monoterapija).
English: OTHER
Maltese: Ilma
English: Not Known
Maltese: Qtugħ ta' nifs
English: Visual field defect, vision blurred, diplopia
Maltese: Difett fil-kamp viżiv, vista mċajpra, tara doppju
English: Table 5 includes adverse reactions reported during clinical trials for recurrent or progressive malignant glioma and following the marketing of TMZ.
Maltese: Tabella 5:Reazzjonijiet avversi f'pazjenti bi glijoma malinna rikurrenti jew progressiva
English: LIST OF EXCIPIENTS Contains lactose.
Maltese: Dan il-prodott mediċinali fih lactose.
English: The major route of 14C elimination is renal.
Maltese: Il-mod ewlieni tal-eliminazzjoni ta' 14C huwa mill-kliewi.
English: How to store Temozolomide Accord Contents of the pack and other information
Maltese: Kif taħżen Temozolomide Accord Kontenut tal-pakkett u informazzjoni oħra
English: prolonged pancytopenia, aplastic anaemia† Neoplasm benign, malignant and unspecified Very rare:
Maltese: Ġilda titqaxxar, reazzjoni ta' sensitività għad-dawl, lewn tal-ġilda anormali
English: Temozolomide Accord 100 mg hard capsules have a white body, a pink cap, and are imprinted ‘TMZ' on cap and ‘100' on body with black ink.
Maltese: Temozolomide Accord 100 mg kapsuli ibsin għandhom korp abjad, ras roża u fuqhom hemm stampat b'linka sewda ‘TMZ' fuq ir-ras u ‘100' fuq il-korp.
English: CTC non-haematological toxicity (except for alopecia, nausea, vomiting) CTC Grade 2
Maltese: Tossiċità mhux ħematoloġika CTC (ħlief għal alopeċja, dardir, rimettar)
English: The hard capsules are white/white, hard gelatin capsules imprinted with ‘TMZ' on cap & ‘250' on body.
Maltese: Il-kapsuli ibsin jikkonsistu minn kapsuli tal-ġelatin ibsin ta' lewn abjad/abjad, b'‘TMZ' fuq ir-ras u ‘250' fuq il-korp.
English: Stomatitis, diarrhoea, abdominal pain, dyspepsia, dysphagia
Maltese: Emoraġija, edima, edima fir-riġlejn Emoraġija, trombosi tal-vini profondi,edima fir-riġlejn
English: Micturition frequency, urinary incontinence
Maltese: Tgħaddi awrina aktar mis-soltur, inkontinenza tal-awrina
English: Dose in Cycle 1 (monotherapy) is 150 mg/m2 once daily for 5 days followed by 23 days without treatment.
Maltese: Id-doża f'Ċiklu 1 (monoterapija) hija ta' 150 mg/m2 darba kuljum għal 5 ijiem segwita b'23 jum mingħajr kura.
English: Remarks
Maltese: TIKKETTAR
English: Temozolomide Accord 20 mg hard capsules have a white body, a yellow cap, and are imprinted ‘TMZ' on cap and ‘20' on body with black ink.
Maltese: Temozolomide Accord 20 mg kapsuli ibsin għandhom korp abjad, ras safranija u fuqhom hemm stampat b'linka sewda ‘TMZ' fuq ir-ras u ‘20' fuq il-korp.
English: Adult patients with newly - diagnosed glioblastoma multiforme
Maltese: Għadd assolut tan-newtrofili
English: - if you feel sick or vomit, which are very common side effects of Temozolomide (see section 4).
Maltese: jekk tħossok marid jew tirremetti, li huma effetti sekondarji komuni ħafna ta' Temozolomide (ara sezzjoni 4).
English: The hard capsules are pink/white hard gelatin capsules, imprinted ‘TMZ' on cap & ‘100' on body.
Maltese: Il-kapsuli ibsin jikkonsistu minn kapsuli tal-ġelatin iebes ta' lewn roża/abjad, b'‘TMZ' fuq ir-ras u ‘100' fuq il-korp.
English: After oral administration to adult patients, TMZ is absorbed rapidly, with peak concentrations reached as early as 20 minutes post administration (mean times between 0.5 and 1.5 hours).
Maltese: Wara l-għotja orali lill-pazjenti adulti, TMZ jiġi assorbit malajr, bl-ogħla konċentrazzjonijiet jintlaħqu 20 minuta jew inqas wara li jkun ingħata (medja tal-ħin bejn 0.5 u 1.5 sigħat).
English: Each sachet contains 1 hard capsule.
Maltese: INDIVIDWALI 1 kapsula iebsa
English: Type III amber glass bottles with polypropylene child-resistant closures and a desiccant, containing 5 or 20 capsules
Maltese: Fliexken tal-ħġieġ ambra ta' Tip III b'tappijiet tal-polypropylene reżistenti għal ftuħ u b'dessikanti, li fihom 5 jew 20 kapsula..
English: Temozolomide Accordshould be administered in the fasting state.
Maltese: Temozolomide Accord m'għandux jingħata lil nisa waqt it-tqala.
English: Erythema multiforme, erythroderma, urticaria, exanthema General disorders and administration site conditions Very common:
Maltese: Eritema multiforme, eritroderma, urtikarja, eksantema Disturbi ġenerali u kundizzjonijiet ta' mnejn jingħata Komuni ħafna:
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Temozolomide Accord 20 mg hard capsules temozolomide
Maltese: IL-PRODOTT MEDIĊINALI Temozolomide Accord 20 mg kapsuli ibsin
English: Haemorrhage, oedema, oedema leg
Maltese: Dijarea, uġigħ ta' żaqq, dispepsja
English: EU/1/10/615/013 EU/1/10/615/014 EU/1/10/615/031 EU/1/10/615/032
Maltese: EU/1/10/615/031 EU/1/10/615/032
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Temozolomide Accord 250 mg hard capsules temozolomide
Maltese: IL-PRODOTT MEDIĊINALI Temozolomide Accord 250 mg kapsuli ibsin
English: 5 PHARMACOLOGICAL PROPERTIES
Maltese: GĦAMLA FARMAĊEWTIKA
English: CTC Grade 3 or 4 a: Treatment with concomitant TMZ can be continued when all of the following conditions are met: absolute neutrophil count ≥ 1.5 x 109/l; thrombocyte count ≥ 100 x 109/l; CTC nonhaematological toxicity ≤ Grade 1 (except for alopecia, nausea, vomiting).
Maltese: Il-kura b'TMZ mogħti b'mod konkomitanti tista' titkompla meta dawn il-kundizzjonijiet ikunu sodisfaċenti: għadd assolut tan-newtrofili ≥ 1.5 x 109/l; għadd tat-tromboċiti ≥ 100 x 109/l; tossiċità mhix ematoloġika CTC ta' ≤ Grad 1 (ħlief għal alopeċja, dardir, rimettar).
English: Analysis of population-based pharmacokinetics of TMZ revealed that plasma TMZ clearance was independent of age, renal function or tobacco use.
Maltese: Analiżi tal-farmakokinetika ta' TMZ bbażata fuq il-popolazzjoni wrew li t-tneħħija mill-plażma ta' TMZ kienet indipendenti mill-età, il-funzjoni tal-kliewi jew l-użu tat-tabakk.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Temozolomide Accord 5 mg hard capsules temozolomide
Maltese: IL-PRODOTT MEDIĊINALI Temozolomide Accord 5 mg kapsuli ibsin
English: capsule shell:
Maltese: il-qoxra tal-kapsula:
English: EU/1/10/615/009 EU/1/10/615/010 EU/1/10/615/029 EU/1/10/615/030
Maltese: EU/1/10/615/029 EU/1/10/615/030
English: There are reports of patients who have taken the recommended dose for more than 5 days of treatment (up to 64 days) with adverse reactions reported including bone marrow suppression, with or without infection, in some cases severe and prolonged and resulting in death.
Maltese: Hemm rapporti ta' pazjenti li ħadu d-doża rrakkomandata għal aktar mill-5 ijiem tat-trattament (sa 64 jum) b'reazzjonijiet avversi rrappurtati li jinkludu soppressjoni tal-mudullun, b'infezzjoni jew mingħajr infezzjoni, f'xi każijiet li kienu serji u fit-tul u li wasslu għall-mewt.
English: Table 4 provides treatment-emergent adverse reactions in patients with newly-diagnosed glioblastoma multiforme during the concomitant and monotherapy phases of treatment.
Maltese: Tabella 4 turi reazzjonijiet avversi li tfaċċaw mal-kura f'pazjenti li jkunu għadhom kif ġew dijanjostikati bi glijoblastoma multiforme waqt il-fażijiet ta' terapija konkomitanti u monoterapija.
English: The pharmacokinetics of TMZ were comparable in patients with normal hepatic function and in those with mild or moderate hepatic impairment.
Maltese: Il-farmakokinetika ta' TMZ kienet kumparabbli f'pazjenti b'funzjoni epatika normali u f'dawk b'indeboliment epatiku ħafif jew moderat.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu.
English: After oral administration of 14C-labelled TMZ, mean faecal excretion of 14C over 7 days post-dose was 0.8%
Maltese: Wara li jingħata millħalq, TMZ immarkat bis-14C, il-medja tal-ammont ta' 14C fl-ippurgar 'l fuq minn 7 ijiem wara d-doża kienet 0.8% li tindika assorbiment komplet.
English: The hardcapsules are yellow/ white hard gelatin capsules, imprinted ‘TMZ' on cap & ‘20' on body.
Maltese: Il-kapsuli ibsin jikkonsistu minn kapsuli tal-ġelatin iebes ta' lewn isfar/abjad, b'‘TMZ' fuq ir-ras u ‘20' fuq il-korp.
English: NAME OF THE MEDICINAL PRODUCT Temozolomide Accord 140 mg hard capsules.
Maltese: IL-PRODOTT MEDIĊINALI Temozolomide Accord 140 mg kapsuli ibsin
English: If ANC falls to < 1.0 x 109/l or the platelet count is < 50 x109/l during any cycle, the next cycle should be reduced one dose level (see section 4.2).
Maltese: Jekk l-ANC jaqa' taħt 1.0 x 109/l jew l-għadd tal-plejtlets ikun < 50 x 109/l waqt xi ċiklu, iċ-ċiklu li jmiss għandu jitnaqqas b'livell ta' doża waħda (ara sezzjoni 4.2).
English: In a separate phase I study, administration of TMZ with ranitidine did not result in alterations in the extent of absorption of temozolomide or the exposure to its active metabolite monomethyl triazenoimidazole carboxamide (MTIC).
Maltese: Fi studju separat ta' fażi I, l-għotja ta' TMZ ma' ranitidine ma bidilx il-grad ta' assorbiment ta' TMZ jew l-espożizzjoni għal metabolit attiv tiegħu monomethyl triazenoimidazole carboxamide (MTIC).
English: Infection, candidiasis oral
Maltese: Infezzjoni, kandidijasi fil-ħalq
English: The hard capsules are maroon/white, hard gelatin capsules, imprinted with ‘TMZ' on cap & ‘180' on body.
Maltese: Il-kapsuli ibsin jikkonsistu minn kapsuli tal-ġelatin iebes ta' lewn kannella/abjad, b'‘TMZ ‘stampat fuq ir-ras u ‘180' fuq il-korp.
English: PHARMACEUTICAL FORM Hard capsule.
Maltese: Qoxra tal-kapsula
English: Haemorrhage, deep venous thrombosis, oedema leg
Maltese: • żieda taz-zokkor fid-demm, telf ta' piż
English: The reduction of blood cells is usually temporary, but in some cases may be for longer and may lead to a very severe form of anaemia (aplastic anaemia).
Maltese: It-tnaqqis taċ-ċelluli fid-demm normalment ma jdumx, imma f'xi każijiet jista' jieħu fit-tul u jista' jwassal għal forma serja ta' anemija (anemija aplastika).
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti li għandhom mard ereditarju rari ta' nuqqas ta' tolleranza għal galactose, defiċenza ta' Lapp lactase jew malassorbiment ta' glukosjugalactose m'għandhomx jieħdu din il-mediċina.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Temozolomide Accord 180 mg hard capsules temozolomide
Maltese: IL-PRODOTT MEDIĊINALI Temozolomide Accord 180 mg kapsuli ibsin
English: TMZ interruptiona
Maltese: Twissijiet u prekawzjonijiet
English: Adult patients with newly-diagnosed glioblastoma multiforme:
Maltese: Pazjenti adulti li jkunu għadhom kif ġew dijanjostikati bi glijoblastoma multiforme
English: Diarrhoea, abdominal pain, dyspepsia
Maltese: Newtropenija bid-deni, anemija
English: Thrombocyte count
Maltese: KARTUNA TAL-QRATAS
English: Post-marketing experience
Maltese: TAL-PRODOTT MEDIĊINALI
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: • Pjan tal-ġestjoni tar-riskju (RMP)
English: a severe allergic reaction (rash which might be itchy, wheezing or other breathing difficulty), - uncontrolled bleeding, - Seizures (convulsions), - fever, - chills, - severe headache that does not go away.
Maltese: Ikkuntattja lit-tabib tiegħek minnufih jekk ikollok xi wieħed minn dawn li ġejjin: - reazzjonijiet allergiċi serji (sensittività eċċessiva) (infafet, tħarħir jew xi problemi biex tieħu n nifs), - emorraġija mingħajr kontroll, - aċċessjonijiet (konvulżjonijiet), - deni, - tkexkix ta' bard, - uġigħ ta' ras sever li ma jkunx jista' jbatti.
English: • pneumonia, inflammation of your sinuses, bronchitis, blocked nose, a cold or the flu
Maltese: • pnewmonja, infjammazzjoni tas-sinus tiegħek, bronkite, imnieħer miżdud, riħ jew influwenza
English: • anxiety, depression, changing emotions, inability to fall asleep or stay asleep,
Maltese: • ansjetà, dipressjoni, emozzjonijiet li jinbidlu, ma tkunx kapaċi torqod jew tibqa' rieqed,
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Temozolomide Accord 100 mg hard capsules temozolomide
Maltese: IL-PRODOTT MEDIĊINALI Temozolomide Accord 100 mg kapsuli ibsin
English: Blood and lymphatic system disorders Common:
Maltese: Disturbi tad-demm u tas-sistema limfatika Komuni:
English: Adult patients with newly-diagnosed glioblastoma multiforme
Maltese: 6.3 Żmien kemm idum tajjeb il-prodott mediċinali
English: However, elderly patients (>70 years of age) appear to be at increased risk of neutropenia and thrombocytopenia (see section 4.4).
Maltese: Madankollu, jidher li pazjenti anzjani (>70 sena) għandhom riskju akbar li jkollhom newtropenija u tromboċitopenija (ara sezzjoni 4.4). Metodu ta' kif għandu jingħata
English: Cytotoxic lesions that develop subsequently are thought to involve aberrant repair of the methyl adduct.
Maltese: Ġrieħi ċitotossiċi li jiżviluppaw sussegwentement huma maħsuba li jinvolvu t-tiswija anormali tal-methyl adduct.
English: Then there may be up to 6 treatment cycles, and each one lasts 28 days.
Maltese: Jista' jkun hemm sa 6 ċikli ta' trattament u kull wieħed minnhom idum sejjer għal 28 jum.
English: Dermatitis, dry skin, erythema, pruritus
Maltese: Dermatite, ġilda xotta, ħmura, ħakk Ġilda xotta, ħakk
English: Dose-related reductions in leukocytes and platelets appear to be sensitive indicators of toxicity.
Maltese: It-tnaqqis fil-lewkoċiti u fil-plejtlets relatati mad-doża jidher li huwa indikatur sensittiv tat-tossiċità.
English: 6 PHARMACEUTICAL PARTICULARS
Maltese: PROPRJETAJIET FARMAKOLOĠIĊI
English: A treatment cycle with Temozolomide Accord comprises 28 days.
Maltese: Ċiklu ta' kura b'Temozolomide Accord fih 28 jum.
English: However, elderly patients (> 70 years of age) appear to be at increased risk of neutropenia and thrombocytopenia (see section 4.4).
Maltese: kuljum, għal 5 ijiem jekk ma jkunx hemm tossiċità ematoloġika (ara sezzjoni 4.4).
English: MA (EU) Number (Invented) name Strength Pharmaceutical Form Route of Administration
Maltese: Numru ta' l-EU Isem inventat Qawwa Għamla farmaċewtika
English: Pack size
Maltese: Il-pakkett
English: Date of last renewal: 06 March 2013
Maltese: Data tal-aħħar tiġdid: 6 ta' Marzu 2013
English: Менарини България” ЕООД тел.
Maltese: Менарини България” ЕООД
English: SpA Via R. Follereau 25 24027 Nembro (BG) Italy
Maltese: SpA Via R. Follereau 25 24027 Nembro (BG) L-Italja
English: 24041 Brembate (BG) Italy or
Maltese: 24041 Brembate (BG) L-Italja jew
English: 750 mg tablet: glycerol triacetate, lactose monohydrate, Blue #1/Brilliant Blue FCF Aluminium Lake
Maltese: Pillola 750 mg: glycerol triacetate, lactose monohydrate, Blu #1/Brilliant Blue FCF Aluminium Lake
English: Blue #2/Indigo Carmine Aluminium Lake (E132)
Maltese: Blu #2/Indigo Carmine Aluminium Lake (E132)
English: 375 mg tablet: macrogol, polysorbate 80, Blue #2/Indigo Carmine Aluminium Lake (E132) 500 mg tablet: macrogol, talc, polyvinyl alcohol-part hydrolyzed, iron oxide yellow (E172), iron oxide red (E172)
Maltese: Pillola 375 mg: macrogol, polysorbate 80, Blu #2/Indigo Carmine Aluminium Lake (E132) Pillola 500 mg: macrogol, talc, polyvinyl alcohol-part hydrolyzed, iron oxide yellow (E172), iron oxide red (E172)
English: The adverse event profile was generally similar in the MERLIN-TIMI 36 study.
Maltese: Il-profil ta' l-avveniment avers kien ġeneralment simili fl-istudju MERLIN-TIMI 36.
English: (E133) and Yellow #5/Tartrazine Aluminium Lake (E102)
Maltese: (E133) and Isfar #5/Tartrazine Aluminium Lake (E102)
English: Excipients: Each tablet contains 0.04 mg azo colouring agent E102 and 12.0 mg lactose monohydrate.
Maltese: Kull pillola fiha 0.04 mg sustanza kolorant azo E102 u 12.0 mg lactose monohydrate.
English: Ranolazine is a substrate for P-gp.
Maltese: Ranolazine huwa sottostrat għal P-gp.
English: Portugal A. Menarini Portugal - Farmacêutica, S.A. Tel: +351 210 935 500
Maltese: Menarini Portugal - Farmacêutica, S.A. Tel: +351 210 935 500
English: Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany or
Maltese: Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Il-Ġermanja jew
English: The other ingredients are: hypromellose, magnesium stearate, methacrylic acid-ethyl acrylate copolymer, microcrystalline cellulose, sodium hydroxide, titanium dioxide and carnauba wax.
Maltese: Is-sustanzi l-oħra huma: hypromellose, magnesium stearate, methacrylic acid-ethyl acrylate copolymer, microcrystalline cellulose, sodium hydroxide, titanium dioxide u carnauba wax.
English: This leaflet was last revised in
Maltese: DATA TA' META ĠIET RIVEDUTA
English: Coordination problems
Maltese: Problemi tal-koordinazzjoni
English: 1, Avenue de la Gare, L-1611 Luxembourg Luxembourg
Maltese: 1, Avenue de la Gare, L-1611 Luxembourg
English: Reproductive system and breast disorders Rare: erectile dysfunction.
Maltese: Disturbi fis-sistema riproduttiva u fis-sider Rari: funżjoni erettili ħażina.
English: Polyvinyl alcohol-part hydrolyzed Iron oxide yellow (E172) Iron oxide red (E172) Talc
Maltese: Iron oxide yellow (E172)
English: Rare: angioedema, allergic dermatitis, urticaria, cold sweat, rash.
Maltese: Rari: anġjoedima, dermatite allerġika, urtikarja, għaraq kiesaħ, raxx.
English: United Kingdom A. Menarini Farmaceutica Internazionale S.R.L.
Maltese: Menarini Farmaceutica Internazionale S.R.L.
English: The adverse events, considered to be at least possibly related to treatment, are listed below by body system, organ class, and absolute frequency.
Maltese: L-avvenimenti avversi, ikkunsidrati li huma possibbilment relatati mal-kura, huma elenkati hawn taħt permezz ta' sistema tal-ġisem, klassifika ta' l-organi, u frekwenza assoluta.
English: No data are available
Maltese: Dejta mhux disponibbli
English: Italia A. Menarini Industrie Farmaceutiche Riunite s.r.l.
Maltese: Menarini Industrie Farmaceutiche Riunite s.r.l.
English: Effects of other medicinal products on ranolazine
Maltese: Effetti ta' prodotti mediċinali oħra fuq ranolazine
English: MARKETING AUTHORISATION HOLDER Menarini International Operations Luxembourg S.A.
Maltese: FIS-SUQ Menarini International Operations Luxembourg S.A.
English: Frequencies are 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), and very rare (< 1/10,000).
Maltese: Il-frekwenzi huma ddefiniti bħala komuni ħafna (≥ 1/10), komuni (≥ 1/100 to < 1/10), mhux komuni (≥ 1/1,000 to < 1/100), rari (≥ 1/10,000 to < 1/1,000), u rari ħafna (< 1/10,000).
English: • Elderly (see sections 4.2, 4.8, and 5.2).
Maltese: • Anzjani (ara sezzjonijiet 4.2, 4.8, u 5.2).
English: Concomitant treatment with ketoconazole 200 mg twice daily increased the AUC of ranolazine by 3.0- to 3.9-fold during ranolazine treatment.
Maltese: Kura konkomittanti ma' 200 mg ketoconazole darbtejn kuljum żiedet l-AUC ta' ranolazine bi 3.0- sa 3.9-il-darba waqt kura b'ranolazine.
English: There was a significantly lower incidence of arrhythmias in patients treated with Ranexa (80%) versus placebo (87%), including ventricular tachycardia ≥ 8 beats (5% versus 8%).
Maltese: Kien hemm inċidenza ferm aktar baxxa ta' arritmiji f'pazjenti kkurati b'Ranexa (80%) kontra plaċebo (87%), inklużi takikardja ventrikulari ≥ 8 taħbitiet (5% kontra 8%).
English: Blue #1/Brilliant Blue FCF Aluminium Lake (E133) and Yellow #5/Tartrazine Aluminium Lake (E102)
Maltese: Blu #1/Brilliant Blue FCF Aluminium Lake (E133) u Isfar #5/Tartrazine Aluminium Lake (E102) 6.2 Inkompatibilitajiet
English: Rare: disorientation.
Maltese: Rari: indeboliment tas-smigħ.
English: Do not chew.
Maltese: Menarini Kft.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 09 July 2008
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TA' L-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 9 ta' Lulju 2008