FrancophonIA/ELRC3.0 huggingface dataset:
English: Use with caution when administering Zycortal concurrently with medicinal products which affect either serum sodium or potassium concentrations, or cellular transportation of sodium or potassium, for example: trimethoprim, amphotericin B, digoxin or insulin.
Maltese: Uża b'attenzjoni meta Zycortal jingħata flimkien ma' prodotti mediċinali li jaffettwaw ilkonċentrazzjonijiet ta' sodium jew ta' potassium fis-serum, jew it-trasportazzjoni ċellulari ta' sodium jew ta' potassium, per eżempju: trimethoprim, amphotericin B, digoxin jew insulina.
English: For use as replacement therapy for mineralocorticoid deficiency in dogs with primary hypoadrenocorticism (Addison's disease).
Maltese: Għall-użu bħala terapija ta' sostituzzjoni għal defiċjenza ta' mineralokortikojdi fi klieb b'ipoadrenokortisismu primarju (il-marda ta' Addison).
English: Type I glass vial (containing 4 ml) with a coated chlorobutyl rubber stopper and aluminium seal with a plastic flip-off cap.
Maltese: Kunjett tal-ħġieġ tat-tip I (li fih 4 ml) b'tapp tal-lastku chlorobutyl miksi u siġill tal-aluminju b'għatu flip-off tal-plastik.
English: In the clinical trial, the mean final dose of Zycortal was 1.9 mg/kg (range 1.2-2.5 mg/kg) and the mean final dosing interval was 38.7 ± 12.7 days (range 20-99 days) with the majority of dogs having a dosing interval between 20 and 46 days.
Maltese: Fil-prova klinika, id-doża medja finali ta' Zycortal kienet ta' 1.9 mg/kg (firxa 1.2-2.5 mg/kg) u lintervall tad-dożaġġ medju finali kien ta' 38.7 ± 12.7 ijiem (firxa 20-99 jum) bil-maġġoranza tal-klieb ikollhom intervall tad-dożaġġ bejn 20 u 46 jum.
English: • Clinical signs of polyuria/polydipsia: Decrease the glucocorticoid dose first.
Maltese: • Sinjali kliniċi ta' poliurja/polidipsija:
English: In a clinical trial, very common adverse reactions were polydipsia and polyuria.
Maltese: Fi prova klinika, reazzjonijiet avversi komuni ħafna kienu polidipsija u poliurja.
English: Tailor the dose of Zycortal and the concurrently administered glucocorticoid replacement therapy to the individual dog based on clinical response and normalization of Na⁺ and K⁺ serum concentrations.
Maltese: Fassal id-doża ta' Zycortal u t-terapija ta' sostituzzjoni ta' glukokortikojdi mogħtija fl-istess waqt lill-kelb individwali skont ir-rispons kliniku u n-normalizzazzjoni talkonċentrazzjonijiet fis-serum ta' Na⁺ u K⁺.
English: Re-evaluate the dog and measure the serum sodium/potassium ratio (Na⁺/K⁺ ratio) approximately 10 days after the first dose (which is the time to maximum concentration (Tmax) of desoxycortone).
Maltese: Evalwa l-kelb mill-ġdid u kejjel il-proporzjon ta' sodium/potassium fis-serum (proporzjon Na⁺/K⁺) madwar 10 ijiem wara l-ewwel doża (li huwa ż-żmien biex tintlaħaq konċentrazzjoni massima (Tmax) ta' desoxycortone).
English: After subcutaneous administration of desoxycortone pivalate at a dosage of 11 mg/kg body weight (five times the recommended dosage), the plasma half-life (mean ± standard deviation) is approximately 17 ± 7 days, with a maximum concentration (Cmax) of 13.2 ± 5 ng/ml, and time to maximum concentration (Tmax) of 10 ± 3.5 days.
Maltese: madwar 17 ± 7 ijiem, b'konċentrazzjoni massima (Cmax) ta' 13.2 ± 5 ng/ml, u żmien sakemm tintlaħaq konċentrazzjoni massima (Tmax) ta' 10 ± 3.5 ijiem.
English: CARDBOARD CARTON
Maltese: KARATTERISTIĊI
English: As expected from the pharmacodynamic effects, escalating doses of desoxycortone are associated with a dose-related trend for increased serum sodium, and decreased blood urea nitrogen, serum potassium and urine specific gravity.
Maltese: Kif mistenni mill-effetti farmakodinamiċi, żidiet fid-dożi ta' desoxycortone huma assoċjati ma' tendenza relatata mad-doża għal żieda ta' sodium fis-serum, u tnaqqis tal-urea nitrogen fid-demm, talpotassium fis-serum u tal-gravità speċifika tal-awrina.
English: • Hyperkalaemia, hyponatremia or Na⁺/K⁺ ratio < 27: Decrease the Zycortal dosing interval by 2-3 days or increase the dose.
Maltese: • Iperkalimja, iponatrimija jew proporzjon ta' Na⁺/K⁺ ta' < 27: Naqqas l-intervall tad-dożaġġ ta' Zycortal b'2-3 ijiem jew żid id-doża.
English: Polyuria, polydipsia may be observed.
Maltese: Għandhom mnejn jiġu osservati poliurja u polidipsija.
English: Zycortal replaces the mineralocorticoid hormones only.
Maltese: Zycortal jissostitwixxi l-ormoni mineralokortikojdi biss.
English: • Hypokalaemia, hypernatremia or Na⁺/K⁺ ratio > 32: Decrease the Zycortal dose.
Maltese: • Ipokalimja, ipernatrimija jew proporzjon ta' Na⁺/K⁺ ta' > 32: Naqqas id-doża ta' Zycortal.
English: Dogs with combined glucocorticoid and mineralocorticoid deficiency should also receive a glucocorticoid such as prednisolone in accordance with standard texts.
Maltese: Klieb li għandhom defiċjenza kombinata ta' glukokortikojdi u mineralokortikojdi għandhom jirċievu wkoll glukokortikojd bħal prednisolone skont il-kitba standard.
English: In the kidney, desoxycortone causes sodium and chloride ion retention, and hydrogen and potassium ion excretion, creating an osmotic gradient.
Maltese: Fil-kliewi, desoxycortone jikkawża żamma tal-joni tas-sodium u l-chloride, u tneħħija taljoni tal-hydrogen u l-potassium, u b'hekk joħloq gradjent osmotiku.
English: If the dog is clinically normal and the Day 25 Na⁺/K⁺ ratio is > 32, it is possible to prolong the dosing interval instead of adjusting the dose as described in Table 1.
Maltese: Jekk il-kelb ikun klinikament normali u l-proporzjon ta' Na⁺/K⁺ f'Jum 25 ikun ta' > 32, huwa possibbli li ttawwal l-intervall bejn doża u oħra minflok taġġusta d-doża kif deskritt fit-Tabella 1.
English: Zycortal 25 mg/ml prolonged-release suspension for injection desoxycortone pivalate
Maltese: Zycortal 25 mg/ml suspensjoni għall-injezzjoni li terħi l-mediċina bil-mod desoxycortone pivalate
English: ratio (i.e. 27 to 32) on Day 25, adjust the dose based on the Day 10 Na⁺/K⁺ ratio using the guidelines in Table 1, below.
Maltese: normali (jiġifieri 27 sa 32) f'Jum 25, aġġusta d-doża bbażat fuq il-proporzjon ta' Na⁺/K⁺f'Jum 10 bl-użu tal-linji gwida f'Tabella 1, hawn taħt.
English: Any dog presenting with severe hypovolaemia, dehydration, prerenal azotaemia and inadequate tissue perfusion (also known as “Addisonian crisis”) must be rehydrated with intravenous fluid (saline) therapy before starting treatment with the veterinary medicinal product.
Maltese: Kull kelb li jkollu ipovolemija severa, deidratazzjoni, ażotemija prerenali u perfużjoni mhux adegwata fit-tessuti (magħrufa wkoll bħala “kriżi ta' Addison”) għandu jiġi idratat mill-ġdid b'terapija ta' fluwidu fil-vini (soluzzjoni ta' melħ) qabel tinbeda l-kura bil-prodott mediċinali veterinarju.
English: There is no specific antidote.
Maltese: M'hemm l-ebda antidotu speċifiku.
English: Use an appropriately graduated syringe to accurately administer the required dose volume.
Maltese: Dan huwa importanti b'mod partikolari meta tinjetta volumi żgħar.
English: Table 1: Day 25: Administering the Second Dose of Zycortal If the Day 10 Na⁺/K⁺ ratio is:
Maltese: L-amministrazzjoni tat-tieni doża ta' Zycortal Jekk il-proporzjon ta' Na⁺/K⁺ f'Jum 10 huwa:
English: • If the dog is both clinically normal and has a normal Na+/K+ ratio (i.e. 27 to 32) on Day 25, adjust the dose based on the Day 10 Na⁺/K⁺ ratio using the guidelines in Table 1, below.
Maltese: • Jekk il-kelb ikun klinikament normali u jkollu wkoll proporzjon ta' Na⁺/K⁺ normali (jiġifieri 27 sa 32) f'Jum 25, aġġusta d-doża bbażat fuq il-proporzjon ta' Na⁺/K⁺ f'Jum 10 bl-użu tal-linji gwida f'Tabella 1, hawn taħt.
English: • If the dog is clinically normal and has a Na⁺/K⁺ ratio > 32 on Day 25, either adjust the dose based on the Day 10 Na⁺/K⁺ ratio according to Table 1 or delay the dose (see Prolonging the dosing interval).
Maltese: • Jekk il-kelb ikun klinikament normali u jkollu proporzjon ta' Na⁺/K⁺ ta' > 32 f'Jum 25, aġġusta d-doża bbażat fuq il-proporzjon ta' Na⁺/K⁺ f'Jum 10 skont Tabella 1, jew għati d-doża aktar tard (ara Titwil tal-intervall bejn doża u oħra).
English: If the polyuria/polydipsia persists and the Na⁺/K⁺ ratio is >32, then decrease the dose of Zycortal without changing the dosing interval.
Maltese: Jekk ilpoliurja/polidipsija tippersisti u l-proporzjon ta' Na⁺/K⁺ ikun > 32, naqqas id-doża ta' Zycortal mingħajr ma tbiddel l-intervall tad-dożaġġ.
English: Increase dose to: 2.3 mg/kg body weight Increase dose to: 2.4 mg/kg body weight
Maltese: Żid id-doża għal: 2.3 mg/kg ta' piż tal-ġisem
English: • If the dog is either not clinically normal or if the Na⁺/K⁺ ratio is abnormal on Day 25, adjust the dose of glucocorticoid or Zycortal (see Subsequent doses and long term management).
Maltese: • Jekk il-kelb ma jkunx klinikament normali jew jekk il-proporzjon ta' Na⁺/K⁺ f'Jum 25 ma jkunx normali, aġġusta d-doża tal-glukokortikojd jew ta' Zycortal (ara Dożi sussegwenti u ġestjoni fit-tul).
English: Prior to a stressful situation, consider temporarily increasing the dose of glucocorticoid.
Maltese: Qabel sitwazzjoni stressanti, ikkunsidra li żżid id-doża tal-glukokortikojd b'mod temporanju.
English: 5531 AE Bladel The Netherlands
Maltese: Bladel l-Olanda
English: EMA/456072/2015 EMEA/H/C/000806
Maltese: EMEA/H/C/000806
English: The full EPAR for Cyanokit 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: Cyanokit hydroxocobalamin
Maltese: Cyanokit idrossokobalamina
English: The maximum total dose is 10 g for adults, and 140 mg/kg in children up to a maximum of 10 g.
Maltese: Id-doża massima hija ta' 10 g għall-adulti, u 140 mg/kg fit-tfal sa massimu ta' 10 g.
English: It is given as an infusion over 15 minutes.
Maltese: Jingħata bħal infużjoni fuq 15-il minuta.
English: In the study of smoke inhalation, the response to Cyanokit was assessed as ‘positive' in 31 patients (45%), ‘partial' in 15 (22%) and ‘absent' in 10 (15%).
Maltese: Fl-istudju tal-inalazzjoni ta' duħħan, ir-reazzjoni għal Cyanokit kienet stmata bħala ‘pożittiva' f'31 pazjent (45%), ‘parzjali' fi 15 (22%) u ‘assenti' f'10 (15%).
English: It contains the active substance hydroxocobalamin (vitamin B12a).
Maltese: Fih is-sustanza attiva lidrossokobalamina (vitamin B12a).
English: This is a summary of the European public assessment report (EPAR) for Cyanokit.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Cyanokit.
English: Symptoms of brain damage resolved in 38 of 66 patients.
Maltese: Sintomi ta' ħsara fil-moħħ irrisolvew fi 38 minn 66 pazjent.
English: Other information about Cyanokit
Maltese: Informazzjoni oħra dwar Cyanokit
English: The European Commission granted a marketing authorisation valid throughout the European Union for Cyanokit on 31 November 2007.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Cyanokit fil-31 ta' Novembru 2007.
English: Hydroxocobalamin (vitamin B12a) has been used as a vitamin supplement since the 1950s.
Maltese: L-idrossokobalamina (vitamina B12a) ilha tintuża bħala vitamina supplimentari mill-ħamsinijiet.
English: Cyanokit is a powder to be made up into a solution for infusion (drip) into a vein.
Maltese: Cyanokit huwa trab li jitħallat f'soluzzjoni għal infużjoni (dripp) ġol-vina.
English: Why has Cyanokit been approved?
Maltese: Għaliex ġie approvat Cyanokit?
English: What is Cyanokit?
Maltese: X'inhu Cyanokit?
English: What is the risk associated with Cyanokit?
Maltese: X'inhu r-riskju assoċjat ma' Cyanokit?
English: The active substance in Cyanokit, hydroxocobalamin, reacts with cyanide in the body to form cyanocobalamin, a non-poisonous compound that is removed from the body in the urine.
Maltese: Is-susutanza attiva fi Cyanokit, l-idrossokobalamina, tirreaġixxi maċ-ċjanur fil-ġisem fil-forma ta' cjanokobalamina, kompost mhux velenuż li jitneħħa mill-ġisem permezz tal-urina.
English: Because hydroxocobalamin has an intense red colour, most patients will have dark red colouring of the skin and mucous membranes for up to 15 days and of the urine for up to 35 days after receiving Cyanokit.
Maltese: Minħabba li l-idrossokobalamina għandha kulur aħmar qawwi, l-parti l-kbira tal-pazjenti jkollhom tindis aħmar skur tal-ġilda u tal-membrani mukużi għal sa 15-il jum u tal-urina għal sa 35 jum wara li jirċievu Cyanokit.
English: For adults, the initial dose is 5 g. For children, it is 70 mg per kilogram body weight up to a maximum dose of 5 g. A second dose can be given, depending on how severe the poisoning is and how well the patient is responding.
Maltese: Għat-tfal, hija 70 mg għal kull kilogramm tal-piż tal-ġisem sa doża massima ta' 5 g.
English: However, the CHMP concluded that Cyanokit had advantages over alternative antidotes because it has a good safety profile in patients who have not been poisoned.
Maltese: Madankollu, il-Kumitat ikkonkluda li Cyanokit għandu vantaġġi fuq antidoti alternattivi minħabba li għandu profil ta' sigurtà tajjeb f'pazjenti li ma ġewx ivvelenati.
English: The use of Cyanokit can interfere with the assessment of burns and with laboratory test results.
Maltese: L-użu ta' Cyanokit jista' jxekkel l-istima ta' ħruq u r-riżultati mit-testijiet tal-laboratorju.
English: How has Cyanokit been studied?
Maltese: Kif ġie studjat Cyanokit?
English: This lowers cyanide levels in the body and stops the cyanide fixing itself to an enzyme in cells called cytochrome oxidase, which is important for providing energy in cells.
Maltese: Il-frekwenza ta' effetti sekondarji oħra ta' Cyanokit ma jistgħux jiġu stmati bittagħrif attwalment disponibbli.
English: Cyanide poisoning usually results from exposure to smoke from fire, from breathing or swallowing cyanide, or from getting it onto the skin or mucous membranes (moist body surfaces, such as the lining of the mouth).
Maltese: Is-CHMP ikkonkluda li Cyanokit jidher li huwa antidot taċ-ċjanur ittolerat tajjeb u effiċjenti, abbażi ta' leffetti tiegħu fuq is-sopravivenza u l-prevenzjoni ta' ħsara lill-moħħ.
English: Of the 14 patients whose cyanide exposure was due to something other than smoke inhalation, 10 survived, including seven patients with ‘lethal' levels of cyanide in the blood.
Maltese: Mill-14-il pazjent li l-esponiment tagħhom għaċ-ċjanur kien għal xi ħaġa oħra barra inalazzjoni tadduħħan, 10 issopravivew, inklużi seba' pazjenti b'livelli ‘letali' taċ-ċjanur fid-demm.
English: A risk management plan has been developed to ensure that Cyanokit is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Cyanokit jintuża bl-aktar mod sigur possibbli.
English: Survival was more likely in those who received Cyanokit before their hearts had stopped, who had less severe symptoms of brain damage and who had lower blood cyanide levels.
Maltese: Is-sopravivenza kienet aktar probabbli f'dawk li rċievew Cyanokit qabel ma waqfitilhom qalbhom, li kellhom sintomi ta' ħsara filmoħħ inqas severi u li kellhom livelli aktar baxxi taċ-ċjanur fid-demm.
English: A sticker explaining this is supplied with every pack of Cyanokit.
Maltese: Tikketta li tispjega dan tiġi ma' kull pakkett ta' Cyanokit.
English: The CHMP concluded that Cyanokit appeared to be a well-tolerated and efficient cyanide antidote, based on its effects on survival and the prevention of brain damage.
Maltese: Dan jgħin biex inaqqas l-effetti ta' avvelenament biċċjanur.
English: The decentralised procedures UK/H/6034/001/DC, UK/H/6035/001/DC and UK/H/6176/001/DC started on 23 July 2015.
Maltese: Il-proċeduri deċentralizzati UK/H/6034/001/DC, UK/H/6035/001/DC u UK/H/6176/001/DC bdew fit-23 ta' Lulju 2015.
English: (see Annex I).
Maltese: (ara l-Anness I).
English: The reference Member State (RMS) is the United Kingdom and the concerned Member States (CMS) Austria (AT), Germany (DE), Croatia (HR), Ireland (IE), Luxembourg (LU), France (FR), Belgium (BE), Netherlands (NL), Portugal (PT) and Spain (ES).
Maltese: L-Istat Membru ta' Referenza (RMS, reference Member State) huwa r-Renju Unit u l-Istati Membri kkonċernati (CMS, concerned Member States) l-Awstrija (AT), il-Ġermanja (DE), il-Kroazja (HR), lIrlanda (IE), il-Lussemburgu (LU), Franza (FR), il-Belġju (BE), in-Netherlands (NL), il-Portugall (PT) u Spanja (ES).
English: The results showed that the means of time-adjusted SPIDs in placebo group (mean=6.63, SD=19.79) is significantly lower than either the one of Combination ¼ dose group (mean=19.25, SD=19.99), the Combination ½ dose group (mean=20.44, standard deviation (SD=20.78) or the Combination full dose group (mean=20.12, SD=18.01).
Maltese: Ir-riżultati wrew li l-medji tal-SPIDs aġġustati skont il-ħin fil-grupp talplaċebo (medja=6.63, SD=19.79) huma ħafna iktar baxxi minn dawk f'jew il-Grupp ta' kombinazzjoni ta' ¼ tad-doża (medja=19.25, SD=19.99), il-Grupp ta' kombinazzjoni ta' ½ id-doża (medja=20.44, devjazzjoni standard (SD, standard deviation=20.78) jew il-Grupp ta'
English: Vale Pharmaceuticals submitted to the United Kingdom an application under the decentralised procedure (DCP) for Paracetamol 500mg and Ibuprofen 150mg fixed dose combination on 27 March 2015.
Maltese: Fis-27 ta' Marzu 2015, Vale Pharmaceuticals ippreżentat lir-Renju Unit applikazzjoni skont ilproċedura deċentralizzata (DCP, decentralised procedure) għal Paracetamol 500 mg u Ibuprofen 150 mg kombinazzjoni ta' doża fissa.
English: Ibuprofen is the safest of the NSAIDs and is therefore an optimal choice.
Maltese: Ibuprofen huwa l-aktar sigur mill-NSAIDs u għalhekk huwa għażla ideali.
English: This phase III study was designed as a prospective, parallel-group, double-blind, placebo comparison of the clinical efficacy and safety of fixed dose combination (2 tablets, each tablet containing 500 mg paracetamol and 150 mg ibuprofen) versus its individual components (either 1000 mg paracetamol or 300 mg ibuprofen) and versus placebo in 300 patients suffering of moderate to severe pain due to post-arthroscopy surgery of the knee.
Maltese: III tfassal bħala tqabbil tal-plaċebo prospettiv, ta' grupp parallel, double-blind tal-effikaċja u s-sigurtà klinika tal-kombinazzjoni ta' doża fissa (2 pilloli, kull pillola fiha 500 mg paracetamol u 150 mg ibuprofen) kontra l-komponenti individwali tagħha (jew 1000 mg paracetamol jew 300 mg ibuprofen) u kontra l-plaċebo fi 300 pazjent li jbatu minn uġigħ moderat sa sever minħabba operazzjoni wara l-artroskopija tal-irkoppa.
English: The safety outcomes evaluated were upper gastrointestinal events, myocardial infarction, stroke, renal failure (excluding chronic), congestive heart failure, intentional or accidental overdose, suicidal behaviour and mortality.
Maltese: L-eżiti tas-sigurtà evalwati kienu avvenimenti gastrointestinali fin-naħa ta' fuq, infart mijokardjali, puplesija, insuffiċjenza tal-kliewi (minbarra kronika), insuffiċjenza konġestiva tal-qalb, doża eċċessiva intenzjonali jew aċċidentali, imġiba suwiċidali u mortalità.
English: Major issues on efficacy and safety raised by several CMS remained unresolved and were considered as a potential serious risk to public health; hence the procedure was referred to the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), under Article 29(1) of Directive 2001/83/EC.
Maltese: CMS baqgħu ma ssolvewx u ġew ikkunsidrati bħala riskju serju potenzjali għas-saħħa pubblika; għalhekk il-proċedura ġiet referuta lill-Grupp ta' Koordinazzjoni għal Proċeduri tar-Rikonoxximent Reċiproku u l-Proċedura Deċentralizzata - tal-Bniedem (CMDh, Coordination Group for Mutual Recognition and Decentralised Procedures - Human) skont l-Artikolu 29(1) tadDirettiva 2001/83/KE.
English: The results from AFT-MX-6 are consistent with AFT-MX-1 which in fact further reinforces the validity of the AFT-MX-1 results.
Maltese: Ir-riżultati minn AFT-MX-6 huma konsistenti ma' AFT-MX-1 li fil-fatt ikompli jsaħħaħ mill-ġdid il-validità tar-riżultati ta' AFT-MX-1.
English: In the potential of medication without the supervision by healthcare potential additional risk minimisation measure would be the restriction of the pack size in order not to exceed the maximum daily recommended dose of 3000 / 900 mg paracetamol/ibuprofen (6 tablets) for maximal duration of three days.
Maltese: Fil-potenzjal ta' medikazzjoni mingħajr is-superviżjoni minn professjonista tal-kura tas-saħħa, miżura tal-imminimizzar tar-riskju addizzjonali potenzjali tkun ir-restrizzjoni tad-daqs tal-pakkett sabiex ma tinqabiżx id-doża rakkomandata ta' kuljum massima ta' 3000 / 900 mg paracetamol/ibuprofen (6 pilloli) għal durata massima ta' tlitt ijiem.
English: Secondly the ratio of paracetamol to ibuprofen (3.3:1) is of paramount importance as there is a distinct additive effect in both acute and chronic pain models, which is lost if the ratio is decreased.
Maltese: It-tieni, il-proporzjon ta' paracetamol għal ibuprofen (3.3:1) huwa ta' importanza kruċjali peress li hemm effett addittiv distint kemm fil-mudelli ta' uġigħ akut kif ukoll f'dak kroniku, li jintilef jekk jitnaqqas il-proporzjon.
English: Study AFT -MX6 was another phase III, placebo-controlled, prospective, randomised, double-blind, parallel-design trial with a safety follow-up at Day 30.
Maltese: III, ikkontrollat mill-plaċebo, prospettiv, randomizzat, double-blind, ta' tfassil parallel b'segwitu tas-sigurtà f'Jum 30.
English: The incidence of adverse events is as expected and most commonly involves the gastrointestinal tract.
Maltese: L-inċidenza ta' avvenimenti avversi hija kif mistennija u ħafna drabi tinvolvi l-apparat gastrointestinali.
English: Its objective was to compare the analgesic efficacy and clinical safety of Combination (paracetamol 500mg and ibuprofen 150 mg) with the other 3 treatment groups (paracetamol 500 mg; low dose ibuprofen 150 mg; high dose ibuprofen 300mg) in patients who have painful osteoarthritis of the knee.
Maltese: L-objettiv tiegħu kien li jqabbel l-effikaċja analġeżika u s-sigurtà klinika tal-Kombinazzjoni (paracetamol 500 mg u ibuprofen 150 mg) mat-3 gruppi ta' kura l-oħra (paracetamol 500 mg; doża baxxa ta' ibuprofen 150 mg; doża għolja ta' ibuprofen 300 mg) f'pazjenti li kellhom osteoartrite bl-uġigħ tal-irkoppa.
English: The applicant noted also the PSUR reports which cover over 89 million tablets of market use have not suggested any additional or unexpected risks.
Maltese: L-applikant innota wkoll li rrapporti PSUR li jkopru ‘l fuq minn 89 miljun pillola ta' użu fis-suq ma ssuġġerewx xi riskju addizzjonali jew mhux mistenni.
English: Male and female participants aged 18 and 60 years undergoing surgical removal of least two impacted third molars were eligible for this study.
Maltese: Parteċipanti rġiel u nisa ta' età bejn 18 u 60 sena li kellhom tneħħija kirurġika ta' mill-inqas żewġ molari terzi affettwati kienu eliġibbli għal dan l-istudju.
English: The data obtained in AFT-MX-1 is reinforced by the large Phase III efficacy study AFT-MX-6.
Maltese: III kbir AFT-MX-6.
English: The applicant presented literature search strategy.
Maltese: L-applikant ippreżenta strateġija ta' tfittxija talletteratura.
English: • The Committee considered the notification of the referral initiated by the United Kingdom under Article 29(4) of Directive 2001/83/EC on the basis that France, Germany, Spain and The Netherlands considered that the granting of the marketing authorisation would constitute a potential serious risk to public health.
Maltese: • Il-Kumitat ikkunsidra n-notifika tar-referenza mibdija mir-Renju Unit skont l-Artikolu 29(4) tadDirettiva 2001/83/KE fuq il-bażi li Franza, il-Ġermanja, Spanja u n-Netherlands ikkunsidraw li lgħoti tal-awtorizzazzjoni għat-tqegħid fis-suq jikkostitwixxi riskju serju potenzjali għas-saħħa pubblika.
English: Therefore the risk for prolonged use of the fixed dose combination and Paracetamol or Ibuprofen alone should have a similar risk/benefit profile.
Maltese: Għalhekk ir-riskju ta' użu fit-tul tal-kombinazzjoni ta' doża fissa u Paracetamol jew Ibuprofen waħdu għandu jkollu profil tar-riskju/tal-benefiċċju simili.