FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/13/820/001 14 film-coated tablets EU/1/13/820/002 28 film-coated tablets EU/1/13/820/003 30 film-coated tablets EU/1/13/820/004 42 film-coated tablets EU/1/13/820/005 50 film-coated tablets EU/1/13/820/006 56 film-coated tablets EU/1/13/820/007 60 film-coated tablets EU/1/13/820/008 70 film-coated tablets EU/1/13/820/009 84 film-coated tablets EU/1/13/820/010 90 film-coated tablets EU/1/13/820/011 98 film-coated tablets EU/1/13/820/012 100 film-coated tablets EU/1/13/820/013 112 film-coated tablets
Maltese: EU/1/13/820/001 14-il pillola miksija b'rita EU/1/13/820/002 28 pillola miksija b'rita EU/1/13/820/003 30 pillola miksija b'rita EU/1/13/820/004 42 pillola miksija b'rita EU/1/13/820/005 50 pillola miksija b'rita EU/1/13/820/006 56 pillola miksija b'rita EU/1/13/820/007 60 pillola miksija b'rita EU/1/13/820/008 70 pillola miksija b'rita EU/1/13/820/009 84 pillola miksija b'rita EU/1/13/820/010 90 pillola miksija b'rita EU/1/13/820/011 98 pillola miksija b'rita EU/1/13/820/012 100 pillola miksija b'rita EU/1/13/820/013 112-il pillola miksija b'rita
English: Marketing Authorisation Holder KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Is-Slovenja l-Manifattur
English: Some factors that may raise urine pH (see section 5.2 'Elimination') may necessitate careful monitoring of the patient.
Maltese: Xi fatturi li jistgħu jgħollu l-pH ta' l-awrina (ara sezzjoni 5.2 “Eliminazzjoni”) jistgħu jeħtieġu monitoraġġ bir-reqqa tal-pazjent.
English: Marixino 10 mg film-coated tablets Each film-coated tablet contains 51.45 mg lactose monohydrate.
Maltese: Marixino 10 mg pilloli miksijin b'rita Kull pillola miksija b'rita fiha 51.45 mg lactose monohydrate.
English: Maintenance dose The recommended maintenance dose is 20 mg per day.
Maltese: Doża ta' manteniment Id-doża rakkomandata hi ta' 20 mg kuljum.
English: Memantine-treated patients showed a statistically significantly better effect than placebo-treated patients on the primary endpoints: Alzheimer's disease assessment scale (ADAS-cog) (p = 0.003) and CIBIC-plus (p = 0.004) at week 24 (last observation carried forward (LOCF)).
Maltese: Skala ta' assessjar tal-marda ta' Alzheimer ADAS-cog (p=0.003) u CIBIC-plus (p=0.004) f' Ġimgħa 24 bl-aħħar osservazzjoni miġjuba 'l quddiem (LOCF).
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit web tal-Aġenzija Ewropea għall-Mediċini: http://www.ema.europa.eu
English: Daily doses of 20 mg lead to steady-state plasma concentrations of memantine ranging from 70 to 150 ng/ml (0.5 - 1 μmol) with large interindividual variations.
Maltese: Dożi ta' 20 mg kuljum jwasslu għal konċentrazzjonijiet ta' memantine fil-plażma fi stat fiss f'medda ta' bejn 70 sa 150 ng/ml (0.5 - 1µmol) b'varjazzjonijiet kbar bejn individwu.u ieħor.
English: What Marixino contains - The active substance is memantine hydrochloride.
Maltese: X'fih Marixino - Is-sustanza attiva hi memantine hydrochloride.
English: In clinical trials in mild to severe dementia, involving 1,784 patients treated with memantine and 1,595 patients treated with placebo, the overall incidence rate of adverse reactions with memantine did not differ from those with placebo; the adverse reactions were usually mild to moderate in severity.
Maltese: Fi provi kliniċi f'pazjenti b'dimenzja ħafifa għal moderata, b'1,784 pazjent ikkurat b'memantine u 1,595 pazjent ikkurat bi plaċebo, ir-rata globali ta' reazzjonijiet avversi li seħħew b'memantine ma kinitx differenti min dik tal-plaċebo; ir-reazzjoniiet avversi ġeneralment kienu ħfief għal moderati filqawwa.
English: In the overdose cases below 140 mg or unknown dose the patients revealed symptoms from central nervous system (confusion, drowsiness, somnolence, vertigo, agitation, aggression, hallucination, and gait disturbance) and/or of gastrointestinal origin (vomiting and diarrhoea).
Maltese: Fil-każijiet ta' doża eċċessiva taħt il-140 mg jew doża mhux magħrufa il-pazjenti wrew sintomi li kienu ġejjin mis-sistema nervuża ċentrali (konfużjoni, tħeddil, ngħas, vertiġini, aġitazzjoni, imġieba aggressiva, alluċinazzjoni, u disturbi fil-qagħda tal-mixi) u/jew ta' natura gastro-intestinali (rimettar u dijarea).
English: Marixino 20 mg film-coated tablets Each film-coated tablet contains 102.90 mg lactose monohydrate.
Maltese: Marixino 20 mg pilloli miksijin b'rita Kull pillola miksija b'rita fiha 102.90 mg lactose monohydrate.
English: In another monotherapy study in mild to moderate Alzheimer's disease a total of 470 patients (MMSE total scores at baseline of 11 - 23) were randomised.
Maltese: Fi studju ieħor b'terapija waħda għal marda ta' Alzheimer ħafifa għal moderata, total ta' 470 pazjent (punteġġi totali MMSE mal-linja bażi ta' 11-23) kienu randomizzati.
English: In patients with severe renal impairment (creatinine clearance 5 - 29 ml/min) daily dose should be 10 mg per day.
Maltese: F'pazjenti b'indeboliment sever renali (tneħħija tal-kreatinina 5-29 ml/min) id-doża ta' kuljum għandha tkun 10 mg kuljum.
English: Marixino 10 mg film-coated tablets memantine hydrochloride
Maltese: Marixino 10 mg pilloli miksija b'rita memantine hydrochloride
English: Marixino 20 mg film-coated tablets memantine hydrochloride
Maltese: Marixino 20 mg pillola miksija b'rita memantine hydrochloride
English: - Concomitant use of memantine and amantadine should be avoided, owing to the risk of pharmacotoxic psychosis.
Maltese: - L-użu ta' memantine u amantadine għandu jkun evitat, minħabba r-riskju ta' psikożi farmakotossika.
English: The use of medicinal products called amantadine (for the treatment of Parkinson's disease), ketamine (a substance generally used as an anaesthetic), dextromethorphan (generally used to treat cough) and other NMDA-antagonists at the same time should be avoided.
Maltese: L-użu ta' prodotti mediċinali msejjħa amantadine (għat-trattament tal-marda ta' Parkinson), ketamine (sustanza li ġeneralment tingħata bħala loppju), dextromethorphan (ġeneralment użata għas-sogħla) u antagonisti oħra ta' NMDA fl-istess ħin għandu jkun evitat.
English: Elevated liver function test
Maltese: Test tal-funzjoni tal-fwied għoli Mhux magħruf Epatite
English: White, oval, biconvex film-coated tablet (tablet length: 15.7-16.4 mm, thickness: 4.7-5.7 mm).
Maltese: Pillola miksija b'rita ta' lewn bajdani, ovali, mżaqqha fuq żewġ naħiet (tul tal-pillola:15.7-16.4 mm, ħxuna:4.7-5.7 mm).
English: - There may be a possibility of reduced serum level of hydrochlorothiazide (HCT) when memantine is co-administered with HCT or any combination with HCT.
Maltese: - Jista' jkun hemm possibilità ta' livelli ta' hydrochlorthiazide (HCT) imnaqqsa fis-serum meta memantine jingħata ma' HCT jew kwalunkwe taħlita ma' HCT.
English: No adverse reactions of memantine were noted on male and female fertility.
Maltese: Ma dehru ebda reazzjonijiet avversi ta' memantine fuq il-fertilità maskili u femminili.
English: Relative large overdoses (200 mg and 105 mg/day for 3 days, respectively) have been associated with either only symptoms of tiredness, weakness and/or diarrhoea or no symptoms.
Maltese: Dożi eċċessivi relattivament għoljin (200 mg u 105 mg/jum għal 3-ijiem, rispettivament) kienu assoċjati ma' sintomi ta' għeja biss, dgħjufija u/jew dijarea jew ma ebda sintomu.
English: At the beginning of treatment you will start by using half a 10 mg tablet once a day (1 x 5 mg).
Maltese: Fil-bidu tat-trattament għandek tibda billi tuża nofs pillola ta' 10 mg darba kuljum (1 x 5 mg).
English: A pivotal monotherapy study in a population of patients suffering from moderate to severe Alzheimer's disease (mini mental state examination (MMSE) total scores at baseline of 3 - 14) included a total of 252 outpatients.
Maltese: Studju pivitali b'terapija waħda f'popolazzjoni ta' pazjenti li kienu qed ibatu mill-marda ta' Alzheimer moderata għal severa (eżami żgħir ħafna ta' l-istat mentali (MMSE) punteġġ totali fil-linja bażi ta' 3-14) kien jinkludi 252 outpatient.
English: Latvija KRKA Latvija SIA
Maltese: KRKA Magyarország Kereskedelmi
English: In man, about 80 % of the circulating memantine-related material is present as the parent compound.
Maltese: Fil-bniedem, madwar 80% tal-materjal li għandu x'jaqsam ma' memantine li jkun fiċ-ċirkolazzjoni jinsab bħala s-sustanza mhux mibdula.
English: Children and adolescents Marixino is not recommended for children and adolescents under the age of 18 years.
Maltese: Tfal u adolexxenti Marixino mhux rakkomandat fit-tfal u adolexxenti taħt it-18-il sena.
English: A pivotal monotherapy study of memantine in the treatment of mild to moderate Alzheimer's disease (MMSE total scores at baseline of 10 to 22) included 403 patients.
Maltese: Studju pivitali b'terapija waħda ta' memantine fil-kura tal-marda ta' Alzheimer ħafifa għal moderata (punteġġ totali ta' MMSE mal-linja bażi ta' 10 sa 22) kien jinkludi 403 pazjent.
English: Film-coated tablet
Maltese: Kisja tal-pillola
English: Marixino 10 mg film-coated tablets Marixino 20 mg film-coated tablets
Maltese: Marixino 10 mg pilloli miksijin b'rita Marixino 20 mg pilloli miksijin b'rita
English: Pharmacotherapeutic group: Psychoanaleptics, other anti-dementia drugs, ATC code: N06DX01.
Maltese: Mediċini oħra ta' kontra d-dimenzja, Kodiċi ATC:
English: No genotoxicity has been observed following testing of memantine in standard assays.
Maltese: Ma ġietx osservata l-ebda tossiċità għal ġeni wara testijiet b'memantine f'assaġġi standard.
English: In patients with moderate renal impairment (creatinine clearance 30 - 49 ml/min) daily dose should be 10 mg per day.
Maltese: F'pazjenti b'indeboliment renali moderat (tneħħija tal-kreatinina 3049 ml/min) id-doża għandha tkun 10 mg kuljum.
English: Concomitant use of N-methyl-D-aspartate (NMDA)-antagonists such as amantadine, ketamine or dextromethorphan should be avoided.
Maltese: L-użu fl-istess ħin ta' antagonisti-N-methyl-D-aspartate (NMDA) bħal amantadine, ketamine jew dextromethorphan għandu jkun evitat.
English: When patients were identified with concurrent worsening in all three domains, results showed a statistically significant effect of memantine in preventing worsening, as twice as many placebo-treated patients as memantine-treated patients showed worsening in all three domains (21 % vs. 11 %, p < 0.0001).
Maltese: Meta pazjenti deher li marru għall-agħar fit-tlett oqsma, ir-riżultati wrew effett statistikament sinifikanti ta' memantine biex jevita li jmorru għall-agħar, darbtejn aktar mill-pazjenti ikkurati bi plaċebo hekk kif pazjenti kkurati b'memantine marru għall-agħar fit-tlett oqsma (21% vs. 11%, p0.
English: Uncommon (may affect up to 1 in 100 people): - Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous blood clotting (thrombosis/thromboembolism).
Maltese: Mhux komuni (jistgħu jaffettwaw sa 1 minn kull 100 persuna): - Għeja, infezzjonijiet tal-moffa, konfużjoni, alluċinazzjonijiet, rimettar, mixja anormali,
English: Pancreatitis
Maltese: Pożoloġija
English: Half a 10 mg tablet
Maltese: Nofs pillola ta' 10 mg
English: In the most extreme case of overdose, the patient survived the oral intake of a total of 2000 mg memantine with effects on the central nervous system (coma for 10 days, and later diplopia and agitation).
Maltese: Fl-aktar każ estrem ta' doża eċċessiva, il-pazjent irnexxielu jibqa ħaj meta ħa b'mod orali 2000 mg memantine b'effetti fuq is-sistema nervuża ċentrali (koma għal 10 ijiem, u wara kellu diplopja u aġitazzjoni).
English: From the fourth week on, the usual dose is two tablets once a day (1 x 20 mg).
Maltese: Mir-4 ġimgħa 'l quddiem, id-doża li ġeneralment tingħata hija ta' 2 pilloli darba kuljum (1x20 mg).
English: What Marixino looks like and contents of the pack White, oval, biconvex film-coated tablets, scored on one side (tablet length: 12.2-12.9 mm, thickness: 3.5-4.5 mm).
Maltese: Pillola miksija b'rita ta' lewn bajdani, ovali, mżaqqha fuq żewġ naħiet, b'ferq fuq naħa waħda (tul talpillola: 12,2-12,9 mm, ħxuna:3,5-4,5 mm).
English: Pharmacokinetic/pharmacodynamic relationship
Maltese: Relazzjoni farmaokinetika/farmakodinamika
English: The patient experienced central nervous system symptoms such as restlessness, psychosis, visual hallucinations, proconvulsiveness, somnolence, stupor, and unconsciousness.
Maltese: Il-pazjent kellu sintomi fuq is-sistema nervuża ċentrali fosthom, irrikwitezza, psikożi, alluċinazzjonijiet tal-vista, pro-aċċessjonijiet, ngħas, sturdament u telf mis-sensi.
English: In patients with mild or moderate hepatic impaired function (Child-Pugh A and Child-Pugh B), no dose adjustment is needed.
Maltese: F'pazjenti b'indeboliment epatiku ħafif għal moderat (Child-Pugh A u Child-Pugh B) m'hemmx bżonn ta' tibdil fid-dożaġġ.
English: At a dose of memantine of 20 mg per day the CSF levels match the ki-value (ki = inhibition constant) of memantine, which is 0.5 μmol in human frontal cortex.
Maltese: B'doża ta' 20 mg memantine kuljum il-livelli ta' CSF qablu mal-valur-ki (ki = kostanti ta' limpediment) ta' memantine, li hija 0.5µmol fil-kortiċi anterjuri tal-bniedem.
English: Marixino 20 mg film-coated tablets
Maltese: Marixino 20 mg pilloli miksijin b'rita
English: Not known (frequency cannot be estimated from the available data): - Inflammation of the pancreas, inflammation of the liver (hepatitis) and psychotic reactions
Maltese: Mhux magħruf (il-frekwenza ma tistax tiġi stmata mit-tagħrif disponibbli): - Infjammazzjoni tal-frixa, infjammazzjoni tal-fwied (epatite) u reazzjonijiet psikotiċi
English: Dose titration
Maltese: DATA TA' SKADENZA
English: Marixino belongs to a group of medicines called NMDA-receptor antagonists.
Maltese: Marixino jagħmel parti minn grupp ta' mediċini li jissejħu antagonisti tar-riċettur-NMDA.
English: On the basis of the clinical studies, the recommended dose for patients over the age of 65 years is 20 mg per day (two 10 mg film-coated tablets or one 20 mg film-coated tablet once a day) as described above.
Maltese: Minn studji kliniċi, id-doża rakkomandata għal pazjenti li għandhom 'l fuq minn 65 sena hija 20 mg kuljum (żewġ pilloli miksijin b'rita ta' 10 mg jew pilloli miksijin b'rita waħda ta' 20 mg darba kuljum) kif spjegat hawn fuq.
English: In a clinical study in young healthy subjects, no relevant effect of memantine on the pharmacokinetics of galantamine was observed.
Maltese: Fi studju kliniku li sar fuq pazjenti żgħażagħ b'saħħithom ma dehrx effett rilevanti ta' memantine fuq il-farmakokinetika ta' galantamine.
English: The maximum daily dose is 20 mg per day.
Maltese: Id-doża massima ta' kuljum hija ta' 20 mg kuljum.
English: Dosage The recommended dose of Marixino for adults and older people is 20 mg once a day.
Maltese: Id-doża rakkomandata ta' Marixino għall-adulti u persuni akbar fl-età hija ta' 20 mg darba kuljum.
English: Alkalisation of urine may result from drastic changes in diet, e.g. from a carnivore to a vegetarian diet, or from the massive ingestion of alkalising gastric buffers.
Maltese: Dawn il-fatturi jinkludu bidla drastika tad-dieta, eż. minn dieta li tinkludi l-laħam għal waħda veġetarjana, jew it-teħid ta' ammonti kbar ta' buffers gastriċi alkalini.
English: Only limited experience with overdose is available from clinical studies and post-marketing experience.
Maltese: Hemm biss esperjenza limitata b'doża eċċessiva minn studji kliniċi u esperjenza wara t-tqegħid fis-suq.
English: KRKA, d.d., Novo mesto Šmarješka cesta 6
Maltese: Šmarješka cesta 6
English: Excipient(s) with known effect:
Maltese: - Is-sustanzi l-oħra (eċċipjenti) huma:
English: Week 2 (day 8-14) The patient should take one 10 mg film-coated tablet (10 mg) per day for 7 days.
Maltese: Il-pazjent għandu jieħu pillola miksija b'rita ta' 10 mg (10 mg) kuljum għal 7 t'ijiem.
English: Marixino 10 mg film-coated tablets
Maltese: Marixino 10 mg pilloli miksijin b'rita
English: Dosage in patients with impaired kidney function If you have impaired kidney function, your doctor will decide upon a dose that suits your condition.
Maltese: Il-marda ta' Alzheimer kienet assoċjata ma' dipressjoni, ħsibijiet ta' suwiċidju u suwiċidju.
English: Your doctor should assess your treatment on a regular basis.
Maltese: Il-pazjent irkupra mingħajr ma kellu konsegwenzi permanenti.
English: 0.3 mg Solution for injection Intravitreal use pre-filled syringe (glass)
Maltese: 0.3 mg soluzzjoni għall-injezzjoni
English: Invented name Strength Pharmaceutical Form Route of Administration Packaging Content Package size EU/1/05/325/002 Macugen
Maltese: EU/1/05/325/002 Macugen
English: 1 pre-filled syringe with pre-attached plunger rod, without a needle l t o r
Maltese: Użu għal ġol-vitriju siringa mimlija għal-lest (ħġieġ)
English: Strength
Maltese: Zentiva
English: EU Number
Maltese: Numru ta' l-EU Isem
English: Recordati Industria Chimica e Farmaceutica S.p.A.
Maltese: Industria Chimica e Farmaceutica S.p.A.
English: Date of first authorisation: 15 November 2013 Date of latest renewal: 17 September 2018
Maltese: Data tal-ewwel awtorizzazzjoni: 15 ta' Novembru 2013 Data tal-aħħar tiġdid: 17 ta' Settembru 2018
English: Pharmaserve (North West) Ltd 9 Arkwright Road Astmoor Industrial Estate Runcorn WA7 1NU United Kingdom
Maltese: Pharmaserve (North West) Ltd 9 Arkwright Road Astmoor Industrial Estate Runcorn WA7 1NU Ir-Renju Unit
English: Uncommon Vaginal candidiasis
Maltese: Candidiasis vaġinali
English: Recordati Ireland Ltd. Raheens East Ringaskiddy Co. Cork Ireland
Maltese: Raheens East Ringaskiddy Co. Cork L-Irlanda
English: The systemic clearance is 18 - 64 mL/min/kg.
Maltese: It tneħħija sistemika hija ta' 18 - 64 mL/min/kg.
English: The medicinal product has a rapid onset of action and is effective within 5 minutes of application.
Maltese: Il-prodott mediċinali għandu bidu ta' azzjoni rapidu u huwa effettiv fi żmien 5 minuti mill-applikazzjoni.
English: Uncommon Anorectal discomfort, oral parasthesia
Maltese: Skumdità anorettali, parasthesia orali
English: Lidocaine is reported to be 66% bound by plasma proteins, including alpha-1-acid glycoprotein.
Maltese: Lidocaine huwa rrappurtat li huwa 66% marbut ma' proteini tal-plażma, inkluż alpha-1-acid glycoprotein.
English: Prilocaine is reported to be 55% bound to plasma proteins, including alpha-1-acid glycoprotein.
Maltese: Prilocaine huwa rrapportat li huwa 55% marbut ma' proteini tal-plażma, inkluż alpha-1-acid glycoprotein.
English: Cutaneous spray, solution 6.5 ml
Maltese: Sprej għall-ġilda, soluzzjoni 6.5 mL
English: Frequency of the adverse reactions 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: Il-frekwenza tar-reazzjonijiet avversi hija ddefinita 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),
English: Adverse drug reactions in male glans-penis-treated subjects System Organ Class
Maltese: Reazzjonijiet avversi għal mediċina f'suġġetti rġiel ittrattati fil-pene glans Sistema tal-klassifika talorgani
English: The metal container is pressurised.
Maltese: Il-kontenitur tal-metall huwa taħt pressjoni.
English: The prilocaine metabolite o-toluidine has genotoxic potential in vitro.
Maltese: Il-metabolit ta' prilocaine o-toluidine għandu potenzjal ġenotossiku in vitro.
English: Tel.: + 48 22 206 84 50
Maltese: POLSKA sp. z o.o. Tel.: + 48 22 206 84 50
English: Renal and urinary disorders
Maltese: Disturbi renali u fis-sistema urinarja
English: Also contains: norflurane
Maltese: Fih ukoll: norflurane
English: Fortacin is a combination of two medicines: lidocaine and prilocaine.
Maltese: Fortacin huwa kombinazzjoni ta' żewġ mediċini: lidocaine u prilocaine.
English: The lidocaine metabolite 2,6-xylidine has genotoxic potential in vitro.
Maltese: Ilmetabolit ta' lidocaine 2,6-xylidine għandu potenzjal ġenotossiku in vitro.
English: Animal studies do not indicate reproductive toxicity (see section 5.3).
Maltese: L-istudji fl annimali ma jindikawx tossiċità riproduttiva (ara sezzjoni 5.3).
English: Pharmacotherapeutic group: Anaesthetics, amides, ATC code: N01BB20
Maltese: Anestetiċi, amidi, Kodiċi ATC:
English: Methaemoglobinaemia may be accentuated in patients already taking medicinal products known to induce the condition, e.g. sulphonamides, acetanilid, aniline dyes, benzocaine, chloroquine, dapsone, metoclopramide, naphthalene, nitrates and nitrites, nitrofurantoin, nitroglycerin, nitroprusside, pamaquine, para-aminosalicylic acid, phenobarbital, phenytoin, primaquine and quinine (see section 4.4).
Maltese: chloroquine, dapsone, metoclopramide, naphthalene, nitrati u nitriti, nitrofurantoin, nitroglycerin, nitroprusside, pamaquine, aċidu para-aminosalicylic, phenobarbital, phenytoin, primaquine u quinine(ara sezzjoni 4.4).
English: Lidocaine is largely metabolised in the liver by cytochrome P450 (CYP 3A4) and probably to a minor extent in the skin.
Maltese: Lidocaine huwa prinċipalment metabolizzat fil-fwied minn cytochrome P450 (CYP 3A4) u probabbilment sa ċertu estent fil-ġilda.
English: • Chloroquine, pamaquine, primaquine, quinine - used to treat malaria
Maltese: • Chloroquine, pamaquine, primaquine, quinine - li jintużaw biex jittrattaw il-malarja
English: The most frequent adverse reactions reported with the use of this medicinal product in male patients were local effects of genital hypoaesthesia (4.5%) and erectile dysfunction (4.4%).
Maltese: Ir-rezzjonijiet avversi l-aktar frekwenti rrapportati bl-użu ta' dan il-prodott mediċinali f'pazjenti rġiel kienu effetti lokali tal-ipoesteżija ġenitali (4.5%) u disfunzjoni erettili (4.4%).
English: The elimination half-life of prilocaine following intravenous administration is approximately 10 - 150 minutes.
Maltese: Prilocaine Il-half-life ta' elimazzjoni ta' prilocaine wara l-għoti ġol-vina hija ta' madwar 10 - 150 minuta.
English: These adverse reactions caused discontinuation of treatment in 0.2% and 0.5% of patients, respectively.
Maltese: Dawn ir-reazzjonijiet avversi kkawżaw il-waqfien tat-trattament f'0.2% u 0.5% tal-pazjenti, rispettivament.
English: Recordati Pharmaceuticals Ltd. Tel: + 44 (0) 1491 576 336
Maltese: Tel: + 44 (0) 1491 576 336
English: During the 3 months of the double-blind treatment phase, the geometric mean IELT increased from 0.58 to 3.17 minutes in the Fortacin group and from 0.56 to 0.94 minutes in the placebo group.
Maltese: 3 xhur tal-fażi ta' trattament double blind, il-medja ġeometrika tal-IELT żdiedet minn 0.58 sa 3.17 minuta fil-grupp ta' Fortacin u minn 0.56 sa 0.94 minuta fil-grupp tal-plaċebo.
English: PHARMACEUTICAL FORM
Maltese: Recordati Pharmaceuticals
English: Clinically significant methaemoglobinaemia should be treated with a slow intravenous injection of methylthioninium chloride.
Maltese: Methaemoglobinaemia klinikament sinifikanti għandha tiġi ttrattata b'injezzjoni ġol-vina bil-mod ta' chloride methylthioninium.
English: Prilocaine is rapidly metabolised in both the liver, by cytochrome P450, and in the kidneys by amidases.
Maltese: Prilocaine huwa metabolizzat rapidament kemm fil-fwied, minn cytochrome P450, kif ukoll fil-kliewi minn amidases.
English: Laboratoires BOUCHARA-RECORDATI Tél: + 33 1 45 19 10 00
Maltese: Tél: + 33 1 45 19 10 00
English: • Phenobarbital, phenytoin - used to treat epilepsy
Maltese: • Phenobarbital, phenytoin - li jintużaw biex jittrattaw l-epilessija
English: • heart medicines (anti-arrhythmic medicines)
Maltese: • mediċini għall-qalb (mediċini anti-arritmijaċi)
English: • other local anaesthetics
Maltese: • anestetiċi lokali oħra
English: Human exposure from Fortacin is 20-30 fold less than the minimum dose that did not result in tumours and 200 fold less than the minimum dose that did result in tumours.
Maltese: esponiment tal-bniedem minn Fortacin huwa 20-30 darba anqas mid-doża minima li ma tirriżultax f'tumuri u 200 darba anqas mid-doża minima li rriżultat f'tumuri.
English: How to store Fortacin
Maltese: Tużax Fortacin
English: - The active substances are lidocaine and prilocaine.
Maltese: - Is-sustanzi attivi huma lidocaine u prilocaine.