FrancophonIA/ELRC3.0 huggingface dataset:
English: Systemic nimesulide medicines are available in the following Member States: Bulgaria, Czech Republic, Cyprus, France, Greece, Hungary, Italy, Latvia, Lithuania, Malta, Poland, Portugal, Romania, Slovakia and Slovenia.
Maltese: Mediċini sistemiċi li fihom nimesulide huma disponibbli fl-Istati Membri li ġejjin: fil-Bulgarija, firRepubblika Ċeka, f'Ċipru, fi Franza, fil-Greċja, fl-Ungerija, fl-Italja, fil-Latvja, fil-Litwanja, f'Malta, filPolonja, fil-Portugall, fir-Rumanija, fis-Slovakkja u fis-Slovenja.
English: Outcome of a procedure under Article 31 of Directive 2001/83/EC as amended
Maltese: Riżultat ta' proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE kif emendata
English: Medicines containing nimesulide have been available since 1985 and are authorised in a number of Member States.
Maltese: Mediċini li fihom nimesulide ilhom disponibbli sa mill-1985 u huma awtorizzati f'għadd ta' Stati Membri.
English: It also reviewed data from the published literature, including published clinical studies, reviews and overviews and combined analyses of results from various studies (pooled analyses and meta-analyses).
Maltese: Irreveda wkoll dejta mil-letteratura ppubblikata, inkluż studji kliniċi ppubblikati, reviżjonijiet u rapporti u analiżi kkombinata ta' riżultati minn diversi studji (analiżi miġbura u metaanaliżi).
English: • acute (short-term) pain,
Maltese: • uġigħ akut (perjodu ta' żmien qasir),
English: All information can be found on the Agency website under Regulatory > Human medicines > Referral procedures> Final decisions
Maltese: L-informazzjoni kollha tista' tinstab fuq is-sit tal-Aġenzija taħt Regulatory > Human medicines > Referral procedures> Final decisions
English: The review procedure was triggered by the decision of Ireland's medicines regulatory authority in May 2007 to suspend the marketing authorisation for systemic nimesulide-containing medicines, due to new information regarding cases of fulminant hepatic failure requiring liver transplantation.1 The Committee concluded that the benefits of systemic formulations of nimesulide still outweigh their risks, provided that the use of these medicines is restricted to ensure that the risk of patients developing liver problems is kept to a minimum.
Maltese: Il-proċedura ta' reviżjoni inbdiet mid-deċiżjoni tal-awtorità regolatorja tal-mediċini tal-Irlanda f'Mejju 2007 li tissospendi lawtorizzazzjoni għat-tqegħid fis-suq għal mediċini sistemiċi li fihom nimesulide, minħabba informazzjoni ġdida dwar każijiet ta' insuffiċjenza epatika fulminanti li kienu jeħtieġu trapjant talfwied.
English: • painful osteoarthritis (swelling in the joints) ,
Maltese: • osteoartrite b'uġigħ (nefħa fil-ġogi) ,
English: The European Medicines Agency has completed a review of the safety and effectiveness of systemic medicines containing nimesulide (capsules, tablets, suppositories and powder or granules for oral suspension).
Maltese: L-Aġenzija Ewropea għall-Mediċini temmet reviżjoni tas-sigurtà u l-effikaċja ta' mediċini sistemiċi li fihom nimesulide (kapsuli, pilloli, suppożitorji u trab jew granuli għal sospensjoni orali).
English: The CHMP concluded that nimesulide was associated with an increased risk of liver toxicity compared with other anti-inflammatory treatments.
Maltese: Is-CHMP ikkonkluda li nimesulide kien assoċjat ma' żieda fir-riskju ta' tossiċità tal-fwied meta mqabbel ma' kura anti-infjammatorja oħra.
English: • Patient currently receiving systemic nimesulide for painful osteoarthritis should consult their doctor in order to arrange alternative treatment.
Maltese: • Pazjenti li attwalment qegħdin jirċievu nimesulide sistemiku għal osteoartrite b'uġigħ għandhom jikkonsultaw lit-tabib tagħhom sabiex jiftiehmu dwar kura alternattiva.
English: The Committee noted that the studies looking into the effectiveness of nimesulide in acute pain relief have shown that it is as effective as other NSAID pain killers such as diclofenac, ibuprofen and naproxen.
Maltese: Il-Kumitat innota li l-istudji li investigaw l-effikaċja ta' nimesulide fis-serħan mill-uġigħ akut urew li huwa effettiv daqs NSAIDs oħra kontra l-uġigħ bħal diclofenac, ibuprofen u naproxen.
English: The Committee reviewed available post marketing data from spontaneous reports of side effects, individual study reports and epidemiological (population-based) studies.
Maltese: Il-Kumitat irreveda dejta disponibbli ta' wara t-tqegħid fis-suq minn rapporti spontanji ta' effetti sekondarji, minn rapporti ta' studji individwali u minn studji epidemjoloġiċi (ibbażati fuq ilpopolazzjoni).
English: Why was nimesulide reviewed?
Maltese: Għalxiex ġie rivedut nimesulide?
English: Nimesulide was reviewed in 2007 because of concerns with liver injury.
Maltese: Nimesulide ġie rivedut fl-2007 minħabba tħassib ta' ħsara fil-fwied.
English: To limit the risk of side effects affecting the liver, several restrictions have already been introduced in the past, including restriction to second line treatment, the use of lowest effective doses for the shortest possible duration, and a maximum duration of treatment for acute pain.
Maltese: Biex jiġi limitat dan ir-riskju ta' effetti sekondarji li jaffettwaw lill-fwied, fil-passat diġà ġew introdotti bosta restrizzjonijiet, inkluż restrizzjoni għal kura tat-tieni linja, l-użu talaktar dożi baxxi effetti għall-inqas tul ta' żmien possibbli, u tul massimu ta' kura għall-uġigħ akut.
English: To this effect the Committee recommended that treatment duration should be limited to a maximum of 15 days (packs were also limited to a two-week supply), that nimesulide should be restricted to second line treatment, and that doctors should be clearly informed of the risk.
Maltese: Għalhekk il-Kumitat irrakkomanda li ddewmien tal-kura għandu jiġi limitat għal massimu ta' 15-il ġurnata (il-pakketti ġew limitati wkoll għal provvista ta' ġimagħtejn), li nimesulide għandu jiġi ristrett għall-kura tat-tieni linja, u li t-tobba għandhom jiġu nfurmati b'mod ċar bir-riskju.
English: Consequently, on 19 January 2010, the European Commission asked the CHMP to carry out a full assessment of the benefit-risk balance of nimesulide and to issue an opinion on whether the marketing authorisations for systemic medicine containing nimesulide should be maintained, varied, suspended or withdrawn across the European Union.
Maltese: Bħala konsegwenza, fid-19 ta' Jannar 2010, il-Kummissjoni Ewropea talbet lis-CHMP biex iwettaq evalwazzjoni sħiħa tal-bilanċ tal-benefiċċju-riskju ta' nimesulide u biex joħroġ opinjoni dwar jekk lawtorizzazzjonijiet għat-tqegħid fis-suq għal mediċini sistemiċi li fihom nimesulide għandhomx jinżammu, jiġu varjati, sospiżi jew irtirati madwar l-Unjoni Ewropea.
English: In terms of safety, the Committee noted that nimesulide has the same risk of causing stomach and gut problems as other NSAIDs.
Maltese: F'termini ta' sigurtà, il-Kumitat innota li nimesulide għandu l-istess riskju li jikkawża problemi fl-istonku u fl-imsaren bħal NSAIDs oħra.
English: The CHMP also concluded that a fuller review of nimesulide was needed, that would look at all of the potential risks of the medicine, especially the risk of side effects affecting the stomach and the gut, which were outside the scope of the original review.
Maltese: Is-CHMP ikkonkluda wkoll li kien hemm il-ħtieġa ta' reviżjoni aktar dettaljata ta' nimesulide, li tkun tħares lejn ir-riskji potenzjali kollha tal-mediċina, speċjalment ir-riskju ta' effetti sekondarji li jaffettwaw lill-istonku u lill-imsaren, li kienu barra millkamp ta' applikazzjoni tar-reviżjoni oriġinali.
English: 20 March 2019 EMA/191666/2019
Maltese: 20 ta' Marzu 2019 EMA/191666/2019
English: They are marketed under a variety of names including Algifen, Algifen Neo, Algi-Mabo, Algoblock, Algocalmin, Algopyrin, Algozone, Alindor, Alkagin, Alvotor, Amizolmet, Analgin, Benalgin, Benlek, Berlosin, Buscapina Compositum, Dialgin, Dolocalma, Flamborin, Freshalgin, Gardan, Generalgin, Hexalgin, Litalgin, Locamin, Metagelan, Metalgial, Metamilan, Metamistad, Metapyrin, Metarapid, Nevralgin, Nodoryl, Nolotil, Novalgin, Novalgina, Novalgine, Novaminsulfon, Novocalmin, Panalgorin, Parakofdal, Piafen, Piralgin, Proalgin, Pyralgin, Pyralgina, Quarelin, Scopolan Compositum, Spasmalgon, Spasmoblok, Tempalgin and Tempimet.
Maltese: Dawn jitqiegħdu fis-suq taħt varjetà ta' ismijiet inkluż Algifen, Algifen Neo, Algi-Mabo, Algoblock, Algocalmin, Algopyrin, Algozone, Alindor, Alkagin, Alvotor, Amizolmet, Analgin, Benalgin, Benlek, Berlosin, Buscapina Compositum, Dialgin, Dolocalma, Flamborin, Freshalgin, Gardan, Generalgin, Hexalgin, Litalgin, Locamin, Metagelan, Metalgial, Metamilan, Metamistad, Metapyrin, Metarapid, Nevralgin, Nodoryl, Nolotil, Novalgin, Novalgina, Novalgine, Novaminsulfon, Novocalmin, Panalgorin, Parakofdal, Piafen, Piralgin, Proalgin, Pyralgin, Pyralgina, Quarelin, Scopolan Compositum, Spasmalgon, Spasmoblok, Tempalgin u Tempimet.
English: E M A /191666/2019
Maltese: EMA/191666/2019
English: Metamizole-containing medicines are available in Austria, Belgium, Bulgaria, Croatia, Czech Republic, Finland, Germany, Hungary, Italy, Latvia, Lithuania, Luxembourg, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia and Spain.
Maltese: Mediċini li fihom Metamizole huma disponibbli fl-Awstrija, il-Belġju, il-Bulgarija, il-Kroazja, irRepubblika Ċeka, il-Finlandja, il-Ġermanja, l-Ungerija, l-Italja, il-Latvja, il-Litwanja, il-Lussemburgu, in-Netherlands, il-Polonja, il-Portugall, ir-Rumanija, is-Slovakkja, is-Slovenja u Spanja.
English: The review of metamizole was initiated on 31 May 2018 at the request of Poland, under Article 31 of Directive 2001/83/EC.
Maltese: Ir-rieżami ta' metamizole nbeda fil-31 ta' Mejju 2018 fuq talba tal-Polonja, skont l-Artikolu 31 tadDirettiva 2001/83/KE.
English: EMA's recommendations were forwarded to the European Commission, which issued a final legally binding decision valid across the EU on 20 March 2019.
Maltese: Ir-rakkomandazzjonijiet tal-EMA ntbagħtu lill-Kummissjoni Ewropea, li ħarġet deċiżjoni finali legalment vinkolanti valida fl-UE kollha fl-20 ta' Marzu 2019.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 20 March 2019.
Maltese: L-opinjoni tas-CHMP intbagħtet lill-Kummissjoni Ewropea, li ħarġet deċiżjoni finali legalment vinkolanti applikabbli fl-Istati Membri kollha tal-UE fl-20 ta' Marzu 2019.
English: Metamizole (also known as dipyrone) is an analgesic medicine (painkiller) that can also relieve fever and muscle spasm.
Maltese: Metamizole (magħruf ukoll bħala dipyrone) huwa mediċina analġeżika (mediċina kontra l-uġigħ) li tista' wkoll ittaffi d-deni u spażmi muskolari.
English: EMA's recommendations include setting a maximum single dose by mouth of 1,000 mg, taken up to 4 times daily (a maximum daily dose of 4,000 mg), in patients from 15 years of age.
Maltese: Ir-rakkomandazzjonijiet tal-EMA jinkludu l-istabbiliment ta' doża singola massima mill-ħalq ta' 1 000 mg, li tittieħed sa 4 darbiet kuljum (doża massima ta' kuljum ta' 4 000 mg), f'pazjenti minn 15-il sena 'l fuq.
English: On 13 December 2018, following a review of medicines containing the painkiller metamizole, EMA recommended that the maximum daily dose of the medicine and the contraindications to its use in pregnancy or women who are breastfeeding should be harmonised for all products on the EU market.
Maltese: Fit-13 ta' Diċembru 2018, wara rieżami ta' mediċini kontra l-uġigħ li fihom metamizole, l-EMA rrakkomandat li d-doża massima ta' kuljum tal-mediċina u l-kontraindikazzjonijiet għall-użu tagħha fittqala jew f'nisa li qed ireddgħu għandha tiġi armonizzata għall-prodotti kollha fis-suq tal-UE.
English: The recommendation addressed inconsistencies in the product information for metamizole medicines, which are marketed in many EU member states to treat severe pain and fever that cannot be controlled with other treatments.
Maltese: Irrakkomandazzjoni indirizzat inkonsistenzi fl-informazzjoni dwar il-prodott għal mediċini metamizole, li huma jitqiegħdu fis-suq f'ħafna Stati Membri tal-UE biex jikkuraw uġigħ sever u deni li ma jistax jiġi kkontrollat b'kuri oħra.
English: A summary of the recommended changes will be published on the EMA website.
Maltese: Sommarju tal-bidliet rakkomandati se jiġi ppubblikat fuq is-sit elettroniku tal-EMA.
English: The Agency reviewed the available information on the way the medicine is distributed in the body, how it works and the limited data on its effects on the unborn child or breast-fed infant.
Maltese: Għalkemm metamizole ilu fis-suq kważi seklu, l-evidenza tal-effetti tiegħu fit-tqala u t-treddigħ hija skarsa.
English: E M A rec ommends aligning dos es of metamizole medicines and their us e during pregnancy and breastfeeding
Maltese: L-EMA tirrakkomanda l-allinjament tad-dożi ta' mediċini metamizole u l-użu tagħhom waqt it-tqala u t-treddigħ.
English: The review has been carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which has adopted the Agency's opinion.
Maltese: Ir-rieżami sar mill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP), responsabbli millmistoqsijiet dwar mediċini għall-użu mill-bniedem, li adotta l-opinjoni tal-Aġenzija.
English: • EMA has completed a review of the painkiller metamizole, used in many EU countries to treat severe pain and fever that cannot be controlled with other treatments.
Maltese: • L-EMA lestiet rieżami tal-mediċina kontra l-uġigħ metamizole, użata f'ħafna pajjiżi tal-UE għall-kura ta' wġigħ sever u deni li ma jistax jiġi kkontrollat b'kuri oħra.
English: • Updated summaries of product characteristics (information for healthcare professionals) and package leaflets for patients which contain the new recommendations will be available nationally following the final legal decision issued by the European Commission.
Maltese: • Sommarji aġġornati tal-karatteristiċi tal-prodott (informazzjoni għall-professjonisti fil-qasam talkura tas-saħħa) u fuljetti ta' tagħrif għall-pazjenti li fihom ir-rakkomandazzjonijiet il-ġodda se jkunu disponibbli fuq livell nazzjonali wara d-deċiżjoni legali finali maħruġa mill-Kummissjoni Ewropea.
English: The full EPAR and risk management plan summary for Ristempa 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: Ristempa contains the active substance pegfilgrastim.
Maltese: Ristempa fih is-sustanza attiva pegfilgrastim.
English: This summary was last updated in 04-2015.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi: 04-2015.
English: Other information about Ristempa
Maltese: Informazzjoni oħra dwar Ristempa
English: The active substance in Ristempa, pegfilgrastim, consists of filgrastim, which is very similar to a human protein called granulocyte colony stimulating factor (G-CSF), that has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Maltese: Is-sustanza attiva f'Ristempa, pegfilgrastim, fiha filgrastim, li hija simili ħafna għall-proteina talbniedem imsejħa fattur ta' stimulanti tal-kolonja tal-granuloċiti (G-CSF), li ġiet 'pegilata' (magħquda ma' sustanza kimika msejħa polietilenglikol).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ristempa on 13 April 2015.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Ristempa valida fl-Unjoni Ewropea kollha fit-13 ta' April 2015.
English: This is a summary of the European public assessment report (EPAR) for Ristempa.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Ristempa.
English: What are the risks associated with Ristempa?
Maltese: X'inhuma r-riskji assoċjati ma' Ristempa?
English: Why is Ristempa approved?
Maltese: Għaliex ġie approvat Ristempa?
English: Ristempa is available as a solution for injection in pre-filled syringes containing 6 mg pegfilgrastim.
Maltese: Ristempa jiġi bħala soluzzjoni għall-injezzjoni f'siringi mimlijin għal-lest li fihom 6 mg pegfilgrastim.
English: For the full list of all side effects and restrictions, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u restrizzjonijiet, ara l-fuljett ta' tagħrif.
English: How is Ristempa used?
Maltese: Kif jaħdem Ristempa?
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku pegfilgrastim
English: A risk management plan has been developed to ensure that Ristempa is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Ristempa jintuża bl-aktar mod sigur possibbli.
English: Ristempa cannot be used in patients with chronic myeloid leukaemia (a cancer of the white blood cells).
Maltese: Ristempa ma jistax jintuża f'pazjenti li jbatu b'lewkimja mjelojde kronika (kanċer taċ-ċelloli bojod taddemm).
English: Chemotherapy (medicines to treat cancer) that is cytotoxic (cell-killing) also kills white blood cells, which can lead to neutropenia (low levels of neutrophils, a type of white blood cell that fights infections) and the development of infections.
Maltese: Il-kimoterapija (mediċini li jikkuraw il-kanċer) li hija ċitotissika (toqtol iċ-ċelloli) toqtol ukoll iċ-ċelloli bojod tad-demm, li jistgħu jwasslu għal newtropenija (livelli baxxi ta' newtrofili, tip ta' ċellola bajda tad-demm li tiġġieled kontra l-infezzjonijiet) u l-iżvilupp ta' infezzjonijiet.
English: The company that makes Neulasta has agreed that its scientific data can be used for Ristempa (‘informed consent').
Maltese: Il-kumpanija li tipproduċi Neulasta qablet li d-data xjentifika tagħha tista' tintuża għal Ristempa (‘kunsens infurmat').
English: Further information can be found in the summary of the risk management plan.
Maltese: Aktar informazzjoni tinstab fis- sommarju tal-pjan tal-ġestjoni tar-riskju.
English: The most common side effects with Ristempa (seen in more than 1 in 10 patients) are bone and muscle pain, headache and nausea (feeling sick).
Maltese: L-effetti sekondarji l-aktar komuni b'Ristempa (li dehru f'aktar minn pazjent 1 minn 10) huma wġigħ fl-għadam u l-muskoli, uġigħ ta' ras u nawżja (dardir).
English: Ristempa has been studied in two main studies involving 467 patients with breast cancer who were being treated with cytotoxic chemotherapy.
Maltese: Ristempa ġie studjat f'żewġ studji prinċipali li jinvolvu 467 pazjent b'kanċer tas-sider li kienu qegħdin jiġu kkurati b'kimoterapija ċitototossika.
English: Ristempa is used to reduce the duration of neutropenia and the occurrence of febrile neutropenia (neutropenia with fever).
Maltese: Ristempa jintuża sabiex inaqqas iż-żmien ta' newtropenija u l-każ li jkun hemm newtropenija febbrili (newtropenija biddeni).
English: It is given as a single 6 mg injection under the skin around 24 hours after the end of each cycle of chemotherapy.
Maltese: Dan jingħata bħala injezzjoni waħda ta' 6 mg taħt il-ġilda madwar 24 siegħa wara t-tmiem ta' kull ċiklu ta' kimoterapija.
English: Because it is pegylated in pegfilgrastim, the rate at which the medicine is removed from the body is decreased, allowing the medicine to be given less often.
Maltese: Minħabba li huwa pegilat f'pegfilgrastim, ir-rata li biha l-mediċina titneħħa mill-ġisem tonqos, u dan jippermetti li lmediċina tingħata anqas sikwit.
English: What is Ristempa and what is it used for?
Maltese: X'inhuma l-benefiċċji ta' Ristempa li ħarġu mill-istudji?
English: In both studies, the patients had severe neutropenia for around 1.7 days during their first chemotherapy cycle, compared with around five to seven days when neither medicine is used.
Maltese: Fiż-żewġ studji, ilpazjenti kienu jbatu minn newtropenija severa għal madwar 1.7 jiem matul l-ewwel ċiklu ta' kimoterapija, meta mqabbel ma' bejn ħames u sebat ijiem meta ma ntużat l-ebda mediċina minnhom.
English: Ristempa was as effective as filgrastim in reducing the duration of severe neutropenia.
Maltese: Ristempa kien effikaċi daqs filgrastim fit-tnaqqis ta' żmien ta' newtropenija severa.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Ristempa's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Ristempa huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: It also cannot be used in patients with myelodysplastic syndromes (a disease in which too many white blood cells are produced, which can develop into leukaemia).
Maltese: Dan jista' jintuża wkoll minn pazjenti bis-sindromi mjelodisplatika (marda li fiha jiġu prodotti ħafna ċelloli bojod tad-demm, li jistgħu jiżviluppaw f'lewkimja).
English: ACTIVITY:
Maltese: ATTIVITÀ:
English: Gamma 112.9498
Maltese: Gamma 112.9498 Gamma 208.3662
English: (listed in section 6).
Maltese: (elenkati fis-sezzjoni 6).
English: 2 mL vial: EU/1/16/1105/001 10 mL vial: EU/1/16/1105/002
Maltese: kunjett 2 mL: EU/1/16/1105/001 kunjett 10 mL:
English: Non carrier added (n.c.a.)
Maltese: L-ebda trasportatur miżjud (Non carrier added - n.c.a.).
English: Radiation Energy (keV)* Abundance (%)
Maltese: Radjazzjoni Enerġija (keV)*
English: …GBq/vial
Maltese: …GBq/kunjett
English: Date of first authorisation: 6 July 2016
Maltese: Data tal-ewwel awtorizzazzjoni: 6 ta' Lulju 2016
English: Organ
Maltese: Organu
English: 15 years old (56.8 kg)
Maltese: 15-il sena (56.8 kg)
English: …GBq/vial at ART ART: {DD/MM/YYYY 12:00 CET }
Maltese: …GBq/kunjett f'ART ART: {JJ/XX/SSSS 12:00 CET}
English: Lutetium (177Lu) is a beta(-)/gamma emitter.
Maltese: Lutetium (177Lu) huwa emittent tal-beta(-)/gamma.
English: Specific activity: …GBq/mg at ART
Maltese: Attività speċifika …GBq/mg f'ART
English: Effective Dose (mSv/MBq)
Maltese: (mSv/MBq)
English: (GBq: GigaBecquerel is the unit in which radioactivity is measured).
Maltese: (GBq: GigaBecquerel hija l-unità li biha titkejjel ir-radjuattività).
English: Up to 9 days from the date of manufacture.
Maltese: Sa 9 ijiem mid-data tal-manifattura.
English: 10 years old (33.2 kg)
Maltese: 10 snin (33.2 kg)
English: 1 year old (9.7 kg)
Maltese: Sena (9.7 kg)
English: Adrenals
Maltese: Adrenali
English: 1 g of the chelating agents should be administered by slow intravenous injection over 3 - 4 minutes or by infusion (1 g in 100 - 250 mL of glucose, or sodium chloride 9 mg/mL (0.9 %) solution for injection).
Maltese: 1 g tal-aġenti kelanti għandha tingħata permezz ta' injezzjoni bil-mod ġol-vina għal 3-4 minuti jew permezz ta' infużjoni (1 g f'100-250 mL ta' glukożju, jew klorur tas-sodju 9 mg/mL (0.9 %) soluzzjoni għall-injezzjoni).
English: Hydrochloric acid solution
Maltese: Aċidu idrokloriku soluzzjoni
English: 5 years old (19.8 kg)
Maltese: 5 snin (19.8 kg)
English: The ART is 12:00 pm (noon) on the scheduled day of radiolabelling as indicated by the customer and can be within 0 to 7 days starting from the day of manufacture.
Maltese: L-ART huwa 12:00 pm (nofsinhar) fuq id-data skedata ta' radjutikkettar kif indikat mill-konsumatur u jista' jkun fi żmien 0 sa 7 ijiem li jibdew mill-jum ta' manifattura.
English: Beta (β−) 149.35
Maltese: Beta (β−) Beta (β−) Beta (β
English: ART: {DD/MM/YYYY 12:00 CET}
Maltese: ART: {JJ/XX/SSSS 12:00 CET}
English: The effective dose to a 73.7 kg adult resulting from an inadvertently injected intravenous activity of 1 GBq would be 534 mSv.
Maltese: Id-doża effettiva għal adult li jiżen 73.7 kg li tirriżulta minn attività injettata b'mod involontarju ġol vina ta' 1 GBq tkun 534 mSv.
English: Of course, the nuclear medicine staff is expected to wear standard radiation protection.
Maltese: Naturalment, il-persunal tal-mediċina nukleari huwa mistenni li jilbes protezzjoni standard għar radjazzjoni.
English: Renal irradiation
Maltese: Irradjazzjoni renali
English: Liver function should be monitored regularly during treatment.
Maltese: Il-funzjoni tal-fwied għandu jiġi monitorat regolarment waqt it-trattament.