FrancophonIA/ELRC3.0 huggingface dataset:
English: Corbilta 175 mg/43.75 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175 tablets).
Maltese: Pilloli Corbilta 175 mg/43.75 mg/200 mg huma disponibbli f'ħames daqsijiet ta' pakketti differenti (10, 30, 100, 130 jew 175 pillola).
English: Paediatric population: The safety and efficacy of Corbilta in children aged below 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Corbilta fit-tfal b'età inqas minn 18-il sena ma ġewx determinati s'issa.
English: Corbilta contains sucrose (1.6 mg/tablet).
Maltese: Corbilta fih sucrose (1.6 mg/pillola).
English: Corbilta 175 mg/43.75 mg/200 mg: light brownish red, oval, unscored film-coated tablets marked with ‘LCE 175' on one side.
Maltese: Corbilta 175 mg/43.75 mg/200 mg: pilloli ovali, ta' lewn aħmar fil-kannella ċar, mingħajr sinjal imnaqqax, immarkati b'‘LCE 175' fuq naħa waħda.
English: Impulse control disorders: Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments containing levodopa including Corbilta (see section
Maltese: Jista' jkun hemm logħob tal-ażżard patoloġiku, żieda fil-libido, ipersesswalità, infiq jew xiri kompulsiv, ikel bl-addoċċ u b'mod kompulsiv f'pazjenti mogħtija agonisti ta' dopamine u/jew trattamenti dopaminerġiċi oħrajn li fihom levodopa inkluż Corbilta (ara sezzjoni 4.4).
English: Corbilta contains sucrose (1.2 mg/tablet).
Maltese: Corbilta fih sucrose (1.2 mg/pillola).
English: Taking into account the PRAC Assessment Report on the PSUR for carbidopa/entacapone/levodopa, the scientific conclusions of the CHMP are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC dwar il-PSUR(s) għal levodopa/carbidopa/entacapone, il-konklużjonijiet xjentifiċi tas-CHMP huma kif ġej:
English: - Each Corbilta 200 mg/50 mg/200 mg tablet contains 200 mg of levodopa, 50 mg of carbidopa and 200 mg of entacapone.
Maltese: - Kull pillola ta' Corbilta 200 mg/50 mg/200 mg fiha 200 mg ta' levodopa, 50 mg ta'carbidopa u 200 mg ta' entacapone.
English: For example, a patient taking one tablet of 50 mg/12.5 mg of levodopa/carbidopa with one tablet of entacapone 200 mg four times daily can take one 50 mg/12.5 mg/200 mg Corbilta tablet four times daily in place of their usual levodopa/carbidopa and entacapone doses.
Maltese: Per eżempju, pazjent li qed jieħu pillola waħda ta' 50 mg/12.5 mg ta' levodopa/carbidopa ma' pillola waħda ta' entacapone 200 mg erba' darbiet kuljum jista' jieħu pillola waħda ta' 50 mg/12.5 mg/200 mg Corbilta erba' darbiet kuljum flok id-dożi tas-soltu ta' levodopa/carbidopa u entacapone.
English: Corbilta 75 mg/18.75 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Maltese: Corbilta 75 mg/18.75 mg/200 mg pilloli miksija b'rita levodopa/carbidopa/entacapone
English: Other antiparkinsonian medicinal products: To date there has been no indication of interactions that would preclude concurrent use of standard antiparkinsonian medicinal products with Corbilta therapy.
Maltese: Prodotti mediċinali kontra l-marda ta' Parkinson oħra: S'issa ma kienx hemm indikazzjoni ta' interazzjonijiet li ma jippermettux l-użu flimkien ta' prodotti mediċinali standard kontra l-marda ta' Parkinson ma' terapija b'Corbilta.
English: Corbilta contains sucrose (1.4 mg/tablet).
Maltese: Corbilta fih sucrose (1.4 mg/pillola).
English: However, a longer dosing interval of Corbilta may be considered for patients who are receiving dialysis therapy (see section 4.2).
Maltese: Madanakollu, jista' jiġi kkunsidrat intervall ta' dożaġġ ta' Corbilta itwal għall-pazjenti li qed jirċievu terapija b'dijalisi (ara sezzjoni 4.2).
English: Therefore, Corbilta and iron preparations should be taken at least 2-3 hours apart (see section 4.8).
Maltese: Għalhekk, Corbilta u preparazzjonijiet li fihom il-ħadid għandhom jittieħdu tal-inqas 2-3 sigħat bogħod minn xulxin (ara sezzjoni 4.8).
English: Ten tablets of Corbilta 150 mg/37.5 mg/200 mg equals 375 mg of carbidopa a day.
Maltese: Għaxar pilloli ta' Corbilta 150 mg/37.5 mg/200 mg huma ekwivalenti għal
English: EU/1/13/859/007 10 film-coated tablets EU/1/13/859/008 30 film-coated tablets EU/1/13/859/009 100 film-coated tablets EU/1/13/859/010 130 film-coated tablets EU/1/13/859/011 175 film-coated tablets
Maltese: EU/1/13/859/007 10 pilloli miksija b'rita EU/1/13/859/008 30 pillola miksija b'rita EU/1/13/859/009 100 pillola miksija b'rita EU/1/13/859/010 130 pillola miksija b'rita EU/1/13/859/011 175 pillola miksija b'rita
English: If you must undergo surgery, please tell your doctor that you are using Corbilta.
Maltese: L-effetti ta' Corbilta jistgħu jiġu mdgħajjfa minn ċertu mediċini.
English: EU/1/13/859/001 10 film-coated tablets EU/1/13/859/002 30 film-coated tablets EU/1/13/859/003 100 film-coated tablets EU/1/13/859/004 130 film-coated tablets EU/1/13/859/005 175 film-coated tablets EU/1/13/859/006 250 film-coated tablets
Maltese: EU/1/13/859/001 10 pilloli miksija b'rita EU/1/13/859/002 30 pillola miksija b'rita EU/1/13/859/003 100 pillola miksija b'rita EU/1/13/859/004 130 pillola miksija b'rita EU/1/13/859/005 175 pillola miksija b'rita EU/1/13/859/006 250 pillola miksija b'rita
English: EU/1/13/859/023 10 film-coated tablets EU/1/13/859/024 30 film-coated tablets EU/1/13/859/025 100 film-coated tablets EU/1/13/859/026 130 film-coated tablets EU/1/13/859/027 175 film-coated tablets EU/1/13/859/028 250 film-coated tablets
Maltese: EU/1/13/859/023 10 pilloli miksija b'rita EU/1/13/859/024 30 pillola miksija b'rita EU/1/13/859/025 100 pillola miksija b'rita EU/1/13/859/026 130 pillola miksija b'rita EU/1/13/859/027 175 pillola miksija b'rita EU/1/13/859/028 250 pillola miksija b'rita
English: EU/1/13/859/034 10 film-coated tablets EU/1/13/859/035 30 film-coated tablets EU/1/13/859/036 100 film-coated tablets EU/1/13/859/037 130 film-coated tablets EU/1/13/859/038 175 film-coated tablets
Maltese: EU/1/13/859/034 10 pilloli miksija b'rita EU/1/13/859/035 30 pillola miksija b'rita EU/1/13/859/036 100 pillola miksija b'rita EU/1/13/859/037 130 pillola miksija b'rita EU/1/13/859/038 175 pillola miksija b'rita
English: Corbilta 175 mg/43.75 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Maltese: Corbilta 175 mg/43.75 mg/200 mg pilloli miksija b'rita levodopa/carbidopa/entacapone
English: How to transfer patients taking levodopa/DDC inhibitor (carbidopa or benserazide) preparations and entacapone tablets to Corbilta a. Patients who are currently treated with entacapone and with standard release levodopa/carbidopa in doses equal to Corbilta tablet strengths can be directly transferred to corresponding Corbilta tablets.
Maltese: Konvulżjonijiet seħħew b'mod rari b'levodopa/carbidopa; iżda relazzjoni kawżali ma' terapija b'levodopa/carbidopa ma ġietx stabbilita.
English: Corbilta 50 mg/12.5 mg/200 mg: brownish or greyish red, round, convex unscored film-coated tablets marked with ‘LCE 50' on one side.
Maltese: Corbilta 50 mg/12.5 mg/200 mg: pilloli miskija b'rita, bla sinjal imnaqqax, ta' lewn aħmar fil-kannella jew fil-griż, tondi, ibbuzzati u mmarkati b'‘LCE 50' fuq naħa waħda.
English: Corbilta 125 mg/31.25 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Maltese: Corbilta 125 mg/31.25 mg/200 mg pilloli miksija b'rita Levodopa/carbidopa/entacapone
English: How to store Corbilta
Maltese: X'fih Corbilta
English: Corbilta 50 mg/12.5 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Maltese: Corbilta 50 mg/12.5 mg/200 mg pilloli miksija b'rita Levodopa/carbidopa/entacapone
English: Corbilta 50 mg/12.5 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Maltese: Corbilta 50 mg/12.5 mg/200 mg pilloli miksija b'rita levodopa/carbidopa/entacapone
English: Corbilta 150 mg/37.5 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Maltese: Corbilta 150 mg/37.5 mg/200 mg pilloli miksija b'rita Levodopa/carbidopa/entacapone
English: EU/1/13/859/029 10 film-coated tablets EU/1/13/859/030 30 film-coated tablets EU/1/13/859/031 100 film-coated tablets EU/1/13/859/032 130 film-coated tablets EU/1/13/859/033 175 film-coated tablets
Maltese: EU/1/13/859/029 10 pilloli miksija b'rita EU/1/13/859/030 30 pillola miksija b'rita EU/1/13/859/031 100 pillola miksija b'rita EU/1/13/859/032 130 pillola miksija b'rita EU/1/13/859/033 175 pillola miksija b'rita
English: Corbilta 100 mg/25 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Maltese: Corbilta 100 mg/25 mg/200 mg pilloli miksija b'rita Levodopa/carbidopa/entacapone
English: Corbilta 200 mg/50 mg/200 mg: dark brownish red, oval, unscored film-coated tablets marked with ‘LCE 200' on one side.
Maltese: Corbilta 200 mg/50 mg/200 mg: pilloli miskija b'rita, bla sinjal imnaqqax, ovali, ta' lewn aħmar skur fil-kannella immarkati b'‘LCE 200' fuq naħa waħda.
English: EU/1/13/859/012 10 film-coated tablets EU/1/13/859/013 30 film-coated tablets EU/1/13/859/014 100 film-coated tablets EU/1/13/859/015 130 film-coated tablets EU/1/13/859/016 175 film-coated tablets EU/1/13/859/017 250 film-coated tablets
Maltese: EU/1/13/859/012 10 pilloli miksija b'rita EU/1/13/859/013 30 pillola miksija b'rita EU/1/13/859/014 100 pillola miksija b'rita EU/1/13/859/015 130 pillola miksija b'rita EU/1/13/859/016 175 pillola miksija b'rita EU/1/13/859/017 250 pillola miksija b'rita
English: EU/1/13/859/018 10 film-coated tablets EU/1/13/859/019 30 film-coated tablets EU/1/13/859/020 100 film-coated tablets EU/1/13/859/021 130 film-coated tablets EU/1/13/859/022 175 film-coated tablets
Maltese: EU/1/13/859/018 10 pilloli miksija b'rita EU/1/13/859/019 30 pillola miksija b'rita EU/1/13/859/020 100 pillola miksija b'rita EU/1/13/859/021 130 pillola miksija b'rita EU/1/13/859/022 175 pillola miksija b'rita
English: Corbilta 200 mg/50 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Maltese: Corbilta 200 mg/50 mg/200 mg pilloli miksija b'rita Levodopa/carbidopa/entacapone
English: Corbilta 200 mg/50 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Maltese: Corbilta 200 mg/50 mg/200 mg pilloli miksija b'rita levodopa/carbidopa/entacapone
English: Corbilta contains three active substances (levodopa, carbidopa and entacapone) in one film-coated tablet.
Maltese: Corbilta fih tliet sustanzi attivi (levodopa, carbidopa u entacapone) f'pillola waħda miksija b'rita.
English: Corbilta 100 mg/25 mg/200 mg: brownish or greyish red, oval, unscored film-coated tablets marked with ‘LCE 100' on one side.
Maltese: Corbilta 100 mg/25 mg/200 mg: pilloli miskija b'rita, bla sinjal imnaqqax, ta' lewn aħmar fil-kannella jew fil-griż, ovali u mmarkati b'‘LCE 100' fuq naħa waħda.
English: - Patients with chronic wide-angle glaucoma may be treated with Corbilta with caution, provided the intra-ocular pressure is well controlled and the patient is monitored carefully for changes in intra-ocular pressure.
Maltese: - Pazjenti bi glawkoma ta' angolu wiesa' kronika jistgħu jiġu kkurati b'Corbilta b'kawtela, dejjem jekk il-pressjoni intra-okulari tkun ikkontrollata sew u li l-pazjent ikun sorveljat b'kawtela għal bidliet fil-pressjoni intra-okulari.
English: See section c.
Maltese: Ara sezzjoni ċ.
English: EMA/139813/2014 EMEA/H/C/000560
Maltese: EMEA/H/C/000560
English: The full EPAR for Protelos can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Protelos
Maltese: Informazzjoni oħra dwar Protelos
English: What is Protelos?
Maltese: X'inhu Protelos?
English: This is a summary of the European public assessment report (EPAR) for Protelos.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Protelos.
English: When looking at results of the two studies taken together, fewer women in the Protelos group developed breaks at any site outside the spine (including the hip) than in the placebo group (331 out of 3,295 with Protelos compared with 389 out of 3,256 for placebo).
Maltese: Meta ġew analizzati r-riżultati taż-żewġ studji flimkien, inqas nisa mill-grupp ta' Protelos kellhom ksur f'għadam ieħor minbarra s-sinsla tad-dahar (inkluż il-ġenbejn) milli dawk mill-grupp tal-plaċebo (331 minn 3,295 bi Protelos meta mqabbla ma' 389 minn 3,256 għall-plaċebo).
English: Protelos is a medicine that contains the active substance strontium ranelate.
Maltese: Protelos hu mediċina li fiha s-sustanza attiva ranelatu tal-istronzju.
English: The most common side effects with Protelos (which may affect more than 1 in 10 people) are hypersensitivity (allergic) skin reactions (rash, itching, urticaria or itchy rash, and swelling beneath the skin known as angioedema) and pain affecting muscles, bones and joints.
Maltese: L-effetti sekondarji l-aktar komuni bl-użu ta' Protelos (li jistgħu jaffettwaw aktar minn persuna minn kull 10) huma reazzjonijiet ipersensittivi (allerġiċi) fil-ġilda (raxx, ħakk, urtikarja jew raxx bil-ħakk, u nefħa taħt il-ġilda magħrufa bħala anġjoedema) u uġigħ li jaffettwa l-muskoli, l-għadam u l-ġogi.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Protelos on 21 September 2004.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Protelos valida fl-Unjoni Ewropea kollha fil-21 ta' Settembru 2004.
English: In the study in male patients, the bone density in the lower part of the spine increased by 7% after one year of treatment in patients taking Protelos, compared with an increase of 1.7% in patients taking placebo.
Maltese: Fl-istudju tal-pazjenti rġiel, id-densità tal-għadam fil-parti t'isfel tas-sinsla tad-dahar żdiedet b'7 % wara sena trattament fil-pazjenti li kienu qed jieħdu Protelos, meta mqabbla ma' 1.7 % f'pazjenti li kienu qed jieħdu l-plaċebo.
English: In the first study, Protelos reduced the risk of new breaks in the spine by 41% over three years: 21% of the 719 women who took Protelos developed a new break in the spine, compared with 33% of the 723 who took placebo.
Maltese: Fl-ewwel studju, Protelos naqqas ir-riskju ta' ksur ġdid fis-sinsla tad-dahar b'41% fuq tliet snin: 21% tas-719-il mara li ħadu Protelos kellhom ksur ġdid fis-sinsla tad-dahar, meta mqabbla ma' 33% tas723 mara li ħadu l-plaċebo.
English: The active substance in Protelos, strontium ranelate, acts on the bone structure.
Maltese: Is-sustanza attiva fi Protelos, ir-ranelatu tal-istronzju, taġixxi fuq l-istruttura tal-għadam.
English: Why has Protelos been approved?
Maltese: Għaliex ġie approvat Protelos?
English: What is the risk associated with Protelos?
Maltese: X'inhu r-riskju assoċjat ma' Protelos?
English: How has Protelos been studied?
Maltese: Kif ġie studjat Protelos?
English: A risk management plan has been developed to ensure that Protelos is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiżgura li Protelos jintuża bl-aktar mod sigur possibbli.
English: Protelos has also been compared with placebo in a main study involving 261 male patients at increased risk of breaking a bone.
Maltese: Protelos tqabbel ukoll ma' plaċebo fi studju ewlieni li involva 261 pazjent raġel b'riskju akbar li jkollhom ksur fl-għadam.
English: Protelos has been studied in almost 7,000 elderly women in two large studies.
Maltese: Protelos ġie studjat f'żewġ studji kbar fi kważi 7,000 mara anzjana.
English: In both studies, Protelos was compared with placebo (a dummy treatment) and the main measure of effectiveness was the reduction in the risk of a new bone break with Protelos.
Maltese: Fiż-żewġ studji, Protelos tqabbel ma' plaċebo (trattament finta) u l-kejl ewlieni tal-effikaċja kien it-tnaqqis fir-riskju ta' ksur ġdid fl-għadam bi Protelos.
English: Protelos is used to treat severe osteoporosis (a disease that makes bones fragile) in post-menopausal women and men who have a high risk of fracture and cannot be treated with other medicines approved for osteoporosis.
Maltese: Protelos jintuża fit-trattament ta' osteoporożi severa (marda li ddgħajjef l-għadam) f'nisa li jkunu għaddew mill-menopawża u fi rġiel li jkunu f'riskju kbir li jkollhom ksur fl-għadam u li ma jistgħux jiġu kkurati b'mediċini oħrajn approvati għal osteoporożi.
English: In addition, education materials are sent to patients and healthcare professionals prescribing Protelos reminding them of the risk of heart and circulatory problems with the medicine and of the need for regular monitoring.
Maltese: Barra minn hekk, jintbagħat materjal edukattivi lill-pazjenti u lill-professjonisti tal-kura tas-saħħa li jippreskrivu Protelos sabiex ifakkarhom fir-riskju ta' problemi tal-qalb u problemi ċirkulatorji bilmediċina u fil-bżonn li jsir monitoraġġ regolari.
English: Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall, since oestrogen helps to keep bones healthy.
Maltese: L-osteoporożi hija aktar komuni fin-nisa wara l-menopawża, meta jonqsu l-livelli tal-ormon femminili estroġenu, peress li dan l-ormon jgħin l-għadam jibqa' f'saħħtu.
English: Protelos must not be used in patients who have or have had venous thromboembolic events (problems due to the formation of blood clots in the veins, such as in the legs or lungs).
Maltese: Protelos ma għandux jintuża fuq pazjenti li qed isofru jew sofrew minn episodji tromboemboliċi venużi (problemi li jirriżultaw mill-formazzjoni tal-emboli tad-demm fil-vini, bħal fis-saqajn jew fil-pulmun).
English: Protelos should be taken at least two hours after food, milk, milk products or calcium supplements, preferably at bedtime.
Maltese: Protelos għandu jittieħed tal-anqas sagħtejn wara li jittieħed xi ikel, ħalib, prodotti tal-ħalib jew supplimenti tal-kalċju, preferibbilment f'ħin l-irqad.
English: 2017, Vol. 27, 3, pp. 269-273.
Maltese: Pediatric Surgery. 2017, Vol. 27, 3, pp. 269-273.
English: 1 Fieler M et al. Metamizole for postoperative pain therapy in 1177 children: A prospective, multicentre, observational, postauthorisation safety study.
Maltese: Metamizole for postoperative pain therapy in 1177 children: A prospective, multicentre, observational, postauthorisation safety study.
English: Grounds for CHMP opinion
Maltese: Raġunijiet għall-opinjoni tas-CHMP
English: 2 Sumpelmann R et al. Metamizole for Postoperative Pain Therapy in Infants Younger than 1 Year.
Maltese: Metamizole for Postoperative Pain Therapy in Infants Younger than 1 Year.
English: The CHMP further noted that two recent studies showed that single intravenous doses of metamizole used for prevention or treatment of postoperative pain were safe in more than 400 infants younger than 1 year (Fieler M et al. 20151, Sümpelmann R et al. 20172).
Maltese: Is-CHMP innota wkoll li żewġ studji riċenti wrew li dożi waħdanin ġol-vini ta' metamizole użati għallprevenzjoni jew il-kura ta' uġigħ wara kirurġija kienu siguri f'aktar minn 400 tarbija iżgħar minn sena (Fieler M et al. 20151, Sümpelmann R et al. 20172).
English: An inhibition of prostaglandin (PG) synthesis is known, based on interaction with different cyclooxygenases (COX), resulting in changes in the arachidonic acid metabolism.
Maltese: Hija magħrufa inibizzjoni ta' sinteżi tal-prostaglandina (PG), abbażi ta' interazzjoni ma' cyclooxygenases (COX) differenti, li tirriżulta f'tibdil fil-metaboliżmu tal-aċidu arakidoniku.
English: The active substance metamizole (also referred to as dipyrone) is a non-addictive pyrazole-type analgesic, spasmolytic and antipyretic drug with weak anti-inflammatory effects.
Maltese: Is-sustanza attiva metamizole (li ssir referenza għaliha wkoll bħala dipyrone) hija mediċina mhux dipendenti, analġeżiku tat-tip pyrazole, spażmolitika u antipiretika b'effetti antiinfjammatorji dgħajfa.
English: Some data suggest that metamizole and its main metabolite 4-methyl-amino-antipyrine (MAA) may have a combined central and peripheral mechanism of action.
Maltese: Xi data tissuġġerixxi li metamizole u lmetabolit ewlieni tiegħu 4-methyl-amino-antipyrine (MAA) jista' jkollhom mekkaniżmu ta' azzjoni ċentrali u periferali kombinat.
English: Besides peripheral inhibition of PG synthesis, central activities have been supposed and documented.
Maltese: Minbarra inibizzjoni ta' sinteżi tal-PG, ġew maħsuba u ddokumentati attivitajiet ċentrali.
English: No data was available to support a change in posology recommendations for the suppository formulations dosed at 100 mg and 200 mg, as well as for the combination products.
Maltese: Ma kien hemm l-ebda data disponibbli biex tappoġġja bidla fir-rakkomandazzjonijiet dwar il-pożoloġija għall-formulazzjonijiet tas-suppositorju ddożati ta' 100 mg u 200 mg, kif ukoll għall-prodotti ta' kombinazzjoni.
English: The Committee also considered that metamizole containing medicinal products should be contraindicated in the third trimester of pregnancy due to the risks of fetal renal impairment and ductus arteriosus constriction.
Maltese: mediċinali li fihom metamizole għandhom jiġu kontraindikati fit-tielet trimestru tat-tqala minħabba r-riskji ta' indeboliment tal-kliewi fil-fetu u kostrizzjoni tad-ductus arteriosus.
English: In children and adolescents up to 14 years old, a dose of 8-16 mg metamizole per kg body weight as a single dose is recommended.
Maltese: Fi tfal u adolexxenti sa 14-il sena, hija rakkomandata doża ta' 8-16 mg metamizole għal kull kg tal-piż tal-ġisem bħala doża waħda.
English: On 26 April 2018, Poland therefore triggered a referral under Article 31 of Directive 2001/83/EC, and requested the CHMP to assess all data available concerning the maximum daily dose and its contraindications on pregnancy and breastfeeding, and issue an opinion as to whether the relevant marketing authorisations should be varied.
Maltese: Għalhekk, fis-26 ta' April 2018, il-Polonja tat bidu għal referenza skont l-Artikolu 31 tadDirettiva 2001/83/KE, u talbet lis-CHMP biex jivvaluta d-data kollha disponibbli dwar id-doża massima ta' kuljum u l-kontraindikazzjonijiet tagħha fit-tqala u t-treddigħ, u biex joħroġ opinjoni dwar jekk lawtorizzazzjonijiet għat-tqegħid fis-suq rilevanti għandhomx jiġu varjati.
English: Metamizole is available as tablets (film tablet or dispersible), oral drops, solution for injection, and suppositories.
Maltese: Metamizole jiġi bħala pilloli (pillola bir-rita jew li tinħall), taqtir orali, soluzzjoni għall-injezzjoni, u suppositorji.
English: In the frame of a Non Urgent Information (NUI) request, the maximum daily dose and contraindications in pregnancy and breastfeeding were investigated for all metamizole-containing products authorised in European Union (EU).
Maltese: Fil-qafas ta' talba ta' Informazzjoni Mhux Urġenti (NUI), id-doża massima ta' kuljum u lkontraindikazzjonijiet fit-tqala u t-treddigħ ġew investigati għall-prodotti kollha li fihom metamizole awtorizzati fl-Unjoni Ewropea (UE).
English: However, there is evidence of fetotoxicity in terms of fetal renal impairment and ductus arteriosus constriction when used in the third trimester and so the Committee considered metamizole should be contraindicated during the third trimester.
Maltese: Madankollu, hemm evidenza ta' fototossiċità f'termini ta' indeboliment tal-kliewi fil-fetu u kostrizzjoni tad-ductus arteriosus meta jintuża fit-tielet trimestru u għalhekk il-Kumitat ikkunsidra li metamizole għandu jiġi kontraindikat waqt it-tielet trimestru.
English: However, it is appropriate to allow, if necessary, a parenteral single dose of 2500 mg metamizole and a maximum daily dose of 5000 mg metamizole.
Maltese: Madankollu, huwa xieraq li tiġi permessa, jekk ikun meħtieġ, doża waħda parenterali ta' 2 500 mg metamizole u doża massima ta' kuljum ta' 5 000 mg.
English: European Journal of Pediatric Surgery.
Maltese: European Journal of
English: As a result of this investigation, it was observed that the maximum daily dose of metamizole reflected in the Product Information of the different medicinal products varies from 1,5 g to 6 g. With regards to contraindication in pregnancy and breastfeeding, discrepancies were also noted.
Maltese: Bħala riżultat ta' din l-investigazzjoni, ġie osservat li d-doża massima ta' kuljum ta' metamizole riflessa fl-Informazzjoni dwar il-Prodott tal-prodotti mediċinali differenti tvarja minn 1,5 g sa 6 g.