FrancophonIA/ELRC3.0 huggingface dataset:
English: Other serious side effects include a disorder related to white blood cells known as differentiation syndrome, a brain condition known as posterior reversible encephalopathy syndrome (PRES) and heart rhythm problems.
Maltese: Effetti sekondarji serji oħra jinkludu disturb relatat ma' ċelloli tad-demm bojod magħrufin bħala sindrome ta' differenzjazzjoni, kundizzjoni tal-moħħ magħrufa bħala sindrome ta' enċefalopatija riversibbli posterjuri (PRES) u problemi tar-ritmu tal-qalb.
English: How does Xospata work?
Maltese: Kif jintuża Xospata?
English: As for all medicines, data on the use of Xospata are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Xospata hija ssorveljata kontinwament.
English: How is Xospata used?
Maltese: Kif jaħdem Xospata?
English: The most common serious side effects (which may affect up to 1 in 10 people) are diarrhoea, increased levels of liver enzymes in the blood, dyspnoea and hypotension.
Maltese: L-effetti sekondarji serji l-aktar komuni (li jistgħu jaffettwaw sa persuna 1 minn kull 10) huma dijarea, livelli miżjuda ta' enzimi tal-fwied fid-demm, dispnea u ipotensjoni.
English: Xospata was shown to prolong patients' lives in comparison to other cancer therapies.
Maltese: Xospata ntwera li jtawwal ħajjet il-pazjenti meta mqabbel ma' terapiji oħra kontra l-kanċer.
English: By blocking FLT3, gilteritinib is expected to stop white blood cell growth and thus slow down the development of the cancer.
Maltese: Billi timblokka l-FLT3, il-gilternitinib hija mistennija li twaqqaf it-tkabbir ta' ċelloli tad-demm bojod u b'hekk jitnaqqas l-iżvilupp tal-kanċer.
English: Xospata received a marketing authorisation valid throughout the EU on 24 October 2019.
Maltese: Din il-ħarsa ġenerali ġiet aġġornata l-aħħar f'10-2019.
English: Side effects with Xospata are those expected of this class of medicines and considered manageable.
Maltese: L-effetti sekondarji bi Xospata huma dawk mistennija minn din il-klassi ta' mediċini u huma kkunsidrati maniġġabbli.
English: In patients who have an FLT3 mutation, FLT3 is overactive and stimulates the growth of too many white blood cells.
Maltese: F'pazjenti li jkollhom mutazzjoni FLT3, l-FLT3 hija attiva żżejjed u tistimula t-tkabbir ta' wisq ċelloli bojod tad-demm.
English: The recommended starting dose is three tablets once daily and can be increased to 5 tablets once daily after 4 weeks depending on the patient's response.
Maltese: Id-doża inizjali rakkomandata hija tliet pilloli darba kuljum u tista' tiżdied għal 5 pilloli darba kuljum wara 4 ġimgħat skont ir-rispons tal-pazjent.
English: Date of opening:__________
Maltese: Data tal-ftuħ:__________
English: Excipient: lactose monohydrate.
Maltese: Eċċipjent: lactose monohydrate.
English: Take Dasselta only as it is prescribed for you.
Maltese: - reazzjonijiet allerġiċi qawwijin, - raxx, - qalb tħabbat mgħaġġla jew irregolari, - taħbit qawwi tal-qalb, - uġigħ fl-istonku, - dardir (tħossok ħażin), - rimettar, - taqlib tal-istonku, - dijarea, - ngħas, - nuqqas ta' rqad, - uġigħ fil-muskoli, - alluċinazzjonijiet, - attakki tal-qamar aċċessjonijiet, - irrikwitezza b'aktar b' żieda fil-moviment tal-ġisem, - infjammazzjoni tal-fwied, - testijiet tal-funzjoni tal-fwied mhux normali.
English: Desloratadine is moderately bound (83 % - 87 %) to plasma proteins.
Maltese: Desloratadine jeħel b'mod moderat (83 %-87 %) mal-proteini tal-plażma.
English: Blister (OPA/Alu/PVC//Alu): 7, 10, 20, 30, 50, 90 and 100 film-coated tablets, in a box.
Maltese: Folji (OPA/Alu/PVC//Alu): 7, 10, 20, 30, 50, 90 u 100 pillola miksija b'rita, ġo kaxxa.
English: What Dasselta contains - The active substance is desloratadine.
Maltese: X'fih Dasselta - Is-sustanza attiva hi desloratadine.
English: Date of first authorisation: 28 November 2011 Date of latest renewal: 16 August 2016
Maltese: Data tal-aħħar tiġdid: 16 ta'Awissu 2016
English: Lactose monohydrate Titanium dioxide (E171) Indigo carmine (E132)
Maltese: Lactose monohydrate Titanium dioxide (E171)
English: Dasselta contains lactose.
Maltese: Dasselta fih lactose.
English: Dasselta is available in carton boxes of 7, 10, 20, 30, 50, 90 and 100 film-coated tablets in blisters and in tablet container of 250 film-coated tablets.
Maltese: Dasselta huwa disponibbli f'kaxxi tal-kartun ta' 7, 10, 20, 30, 50, 90 u 100 pillola miksija b'rita f'folji u f'reċipjent tal-pilloli ta' 250 pillola miksija b'rita.
English: In a clinical trial with 578 adolescent patients, 12 through 17 years of age, the most common adverse event was headache; this occurred in 5.9 % of patients treated with desloratadine and 6.9 % of patients receiving placebo.
Maltese: Fi prova klinika b'578 pazjent adolexxenti, b'età minn 12 sa 17 il sena, l-aktar każ avvers komuni kien uġigħ ta' ras; dan seħħ f'5.9% tal-pazjenti kkurati b'desloratadine u f'6.9% tal-pazjenti li kienu qed jirċievu plaċebo.
English: Pharmacotherapeutic group: Other antihistamines for systemic use, ATC code: R06AX27
Maltese: Kategorija farmakoterapewtika: antiistamini oħra għal użu sistemiku, Kodiċi ATC:
English: Dasselta contains lactose
Maltese: Dasselta fih lactose
English: Tablet container (HDPE, volume 60 ml), PP closure with desiccant: 250 film-coated tablets, in a box.
Maltese: Reċipjent tal-pilloli (HDPE, volum 60 ml), Għatu PP b'dessikant: 250 pillola miksija b'rita ġo kaxxa.
English: Other medicines and Dasselta
Maltese: Mediċini oħra u Dasselta
English: Adverse reactions seen with desloratadine
Maltese: Reazzjonijiet avversi li dehru b'desloratadine
English: Paediatric population Interaction studies have only been performed in adults.
Maltese: Popolazzjoni pedjatrika Studji ta' interazzjoni twettqu biss f'l-adulti.
English: The most frequent of adverse reactions reported in excess of placebo were fatigue (1.2 %), dry mouth (0.8 %) and headache (0.6 %).
Maltese: L-aktar reazzjonijiet avversi frekwenti li kienu rrappurtati aktar minn dak tal-plaċebo kienu għeja (1.2 %), ħalq xott (0.8 %), u uġigħ ta' ras (0.6 %).
English: Light blue, round, film-coated tablets with beveled edges (diameter: 6.5 mm, thickness: 2.3-3.5 mm).
Maltese: Pillola miksija b'rita ta' lewn ċelesti, tonda bi truf inċamfrin (dijametru: 6.5 mm, ħxuna 2.3-3.5 mm).
English: Each film-coated tablet contains 5 mg desloratadine.
Maltese: Kull pillola miksija b'rita fiha 5 mg desloratadine.
English: Desloratadine given at a single daily dose of 7.5 mg did not affect psychomotor performance in clinical trials.
Maltese: Desloratadine mogħti bħala doża waħda kuljum ta' 7.5 mg ma affettwax ilprestazzjonijiet psikomotorei fi provi kliniċi.
English: - The other ingredients in the tablet core are: microcrystalline cellulose (E460), hypromellose (E464), hydrochloric acid (E507), sodium hydroxide (E524), maize starch, lactose monohydrate (see section 2 under »Dasselta contains lactose«.)
Maltese: - Is-sustanzi oħra (l-eċċipjenti) tal-qalba tal-pillola huma microcrystalline cellulose (E460), hypromellose (E464), hydrochloric acid (E507), sodium hydroxide (E524), maize starch, lactose monohydrate (ara sezzjoni 2 taħt »Dasselta fih il-lattozju«) u talc (E553b).
English: Dasselta 5 mg film-coated tablets Desloratadine
Maltese: Dasselta 5 mg pilloli miksija b'rita Desloratadine
English: 7 film-coated tablets 10 film-coated tablets 20 film-coated tablets 30 film-coated tablets 50 film-coated tablets 90 film-coated tablets 100 film-coated tablets for tablet container: 250 film-coated tablets
Maltese: 7 pilloli miksija b'rita 10 pilloli miksijin b'rita 20 pillola miksija b'rita 30 pillola miksija b'rita 50 pillola miksija b'rita 90 pillola miksija b'rita 100 pillola miksija b'rita għar-reċipjent tal-pilloli 250 pillola miksija b'rita
English: Dasselta is indicated in adults and adolescents aged 12 years and older for the relief of symptoms associated with: - allergic rhinitis (see section 5.1), - urticaria (see section 5.1).
Maltese: Dasselta jintuża fl-adulti u fl-adolexxenti minn 12-il sena 'l fuq biex jittaffew is-sintomi assoċjati ma': - rinite allerġika (ara sezzjoni 5.1), - urtikarja (ara sezzjoni 5.1).
English: ), titanium dioxide (E171) and indigo carmine (E132).
Maltese: Indigo carmine (E132)
English: Hypersensitivity to the active substance, to any of the excipients listed in section 6.1 or to loratadine.
Maltese: Sensittività eċċessiva għas-sustanza attiva, jew għal kwalunkwe sustanza mhux attiva elenkata fissezzjoni 6.1, jew għal loratadine.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti bi problemi erditarji rari ta' intolleranza għal galactose, deffiċjenza ta' Lapp lactase jew malassorbiment ta' glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: The efficacy of desloratadine tablets has not been clearly demonstrated in trials with adolescent patients 12 through 17 years of age.
Maltese: L-effikaċja tal-pilloli desloratadine ma ntwerietx b'mod ċar fi provi b'pazjenti adolexxenti minn 12 sa 17-il sena.
English: Metabolism and nutritional disorders
Maltese: Disturbi fil-metaboliżmu u nnutrizzjoni
English: Desloratadine is a non-sedating, long-acting histamine antagonist with selective peripheral H1-receptor antagonist activity.
Maltese: Desloratadine huwa antagonist ta' istamina li ma jħeddilx u li jaħdem fit-tul b'attività antagonista selettiva għar-riċettur-H1 periferali.
English: Fertility There is no data available on male/female fertility.
Maltese: Fertilità M'hemmx dejta disponibbli dwar il-fertilità tal-irġiel/tan-nisa.
English: Dasselta is an antiallergy medicine that does not make you drowsy.
Maltese: Dasselta hija mediċina kontra l-allerġiji li ma traqqdekx.
English: Use caution when taking Dasselta with alcohol.
Maltese: Oqgħod attent meta tieħu Dasselta mal-alkoħol.
English: Tél/Tel: +32 (0) 487 50 73 62 (BE)
Maltese: +32 (0) 487 50 73 62 (BE)
English: An improvement in pruritus of more than 50 % was observed in 55 % of patients treated with desloratadine compared with 19 % of patients treated with placebo.
Maltese: Titjib fil-ħakk ta' aktar minn 50 % deher f'55 % talpazjenti kkurati b'desloratadine imqabbel ma' 19 % tal-pazjenti kkurati bi plaċebo.
English: What Dasselta looks like and contents of the pack Light blue, round, film-coated tablets with beveled edges (diameter: 6.5 mm, thickness: 2.3-3.5 mm).
Maltese: Kif jidher Dasselta u l-kontenut tal-pakkett Pillola miksija b'rita ta' lewn ċelesti, tonda bi truf inċamfrin(dijametru: 6.5 mm, ħxuna 2.3-3.5 mm).
English: These include inhibiting the release of proinflammatory cytokines such as IL-4, IL-6, IL-8, and IL-13 from human mast cells/basophils, as well as inhibition of the expression of the adhesion molecule P-selectin on endothelial cells.
Maltese: Dawn kienu jinkludu inibizzjoni talħelsien ta' ċitokini li jgħinu l-infjammazzjoni bħal IL-4, IL-6, IL-8 u IL-13 miċ-ċelluli mast/bażofili talbniedem, kif ukoll inibizzjoni fl-espressjoni tal-molekula ta' adeżjoni P-selectin fuq iċ-ċelluli endoteljali.
English: Excipient with known effect: Each film-coated tablet contains 16.15 mg lactose (as monohydrate).
Maltese: Kull pillola miksija b'rita fiha 16.15 mg lattozju (bħala monoidrat).
English: In a pharmacokinetic trial in which patient demographics were comparable to those of the general seasonal allergic rhinitis population, 4 % of the subjects achieved a higher concentration of desloratadine.
Maltese: Fi prova farmakokinetika fejn il-karatteristiċi demografiċi tal-pazjenti kienu jaqblu ma' dawk tal popolazzjoni ġenerali b'rinite allerġika tal-istaġun, 4 % tal-individwi kisbu konċentrazzjoni ogħla ta' desloratadine.
English: The degree of accumulation of desloratadine was consistent with its half-life (approximately 27 hours) and a once daily dosing frequency.
Maltese: Il-grad ta' akkumulazzjoni ta' desloratadine kien jaqbel mal- half-life tiegħu (madwar 27 siegħa) u l-frekwenza ta' dożaġġ ta' darba kuljum.
English: Dasselta relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) in adults and adolescents 12 years of age and older.
Maltese: Dasselta itaffi s-sintomi assoċjati ma' rinite allerġika (infjammazzjoni tal-passaġġi fl-imnieħer ikkawżata minn allerġija, pereżempju hay fever jew allerġija għad dust mites) fl-adulti u fl-adolexxenti minn 12-il sena 'l fuq.
English: film-coated tablet for blister:
Maltese: għar-reċipjent tal-pilloli:
English: Dasselta 5 mg film-coated tablets
Maltese: Dasselta 5 mg pilloli miksija b'rita
English: 250 film-coated tablets
Maltese: 250 pillola miksija b'rita
English: In a clinical pharmacology trial desloratadine tablets taken concomitantly with alcohol did not potentiate the performance impairing effects of alcohol (see section 5.1).
Maltese: Fi prova farmakoloġika klinika, pilloli desloratadine li ttieħdu flimkien mal-alkoħol ma żidux l-effetti tal-alkoħol li jxekkel il-prestazzjoni (ara sezzjoni 5.1).
English: Elevations of liver enzymes, increased bilirubin, hepatitis
Maltese: Żieda fl-enżimi tal-fwied, żieda fil-bilirubina, epatite
English: Very rare (the following may affect up to 1 in 10,000 people): - severe allergic reactions, - rash, - pounding or irregular heartbeat, - fast heartbeat, - stomach ache, - feeling sick (nausea), - vomiting, - upset stomach, - diarrhoea, - dizziness, - drowsiness, - inability to sleep, - muscle pain, - hallucinations, - seizures, - restlessness with increased body movement, - liver inflammation, - abnormal liver function tests.
Maltese: F'pazjenti b'rinite allerġika, desloratadine, kien effettiv biex iserraħ sintomi bħal għatis, tnixxija mill-imnieħer, u ħakk, kif ukoll ħakk, dmugħ u ħmura fl-għajnejn, u ħakk fis-saqaf tal-ħalq.
English: Desloratadine effectively controlled symptoms for 24 hours.
Maltese: Desloratadine ikkontrolla s-sintomi b'mod effettiv għal 24 siegħa.
English: TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
Maltese: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Is-Slovenja TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Il-Ġermanja
English: No clinically relevant changes in desloratadine plasma concentrations were observed in multiple-dose ketoconazole and erythromycin interaction trials.
Maltese: Ma ġie osservat l-ebda tibdil kliniku rilevanti tal-konċentrazzjonijiet ta' desloratadine fil-plażma fi provi ta' interazzjoni b'ħafna dożi, ta' ketoconazole u erythromycin.
English: In addition to the established classifications of seasonal and perennial, allergic rhinitis can alternatively be classified as intermittent allergic rhinitis and persistent allergic rhinitis according to the duration of symptoms.
Maltese: Minbarra l-klassifikazzjonijiet stabbiliti tal-istaġun u perenni, rinite allerġika tista' minflok tkun ikklassifikata bħala rinite allerġika intermittenti u rinite allerġika persistenti skont kemm idumu s-sintomi.
English: Nervous system disorders
Maltese: Disturbi fis-sistema nervuża Komuni Rari ħafna
English: Do not use this medicine after the expiry date which is stated on the packaging after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-pakkett wara “EXP”.
English: During the marketing of desloratadine-containing products, the following side effects were reported as:
Maltese: Matul it-tqegħid fis-suq ta' desloratadine, l-effetti sekondarji li ġejjin ġew irrappurtati bħala:
English: In clinical trials in a range of indications including allergic rhinitis and chronic idiopathic urticaria, at the recommended dose of 5 mg daily, undesirable effects with desloratadine were reported in 3 % of patients in excess of those treated with placebo.
Maltese: Fi provi kliniċi ta' medda ta' indikazzjonijiet fosthom rinite allerġika u urtikarja idjopatika kronika, biddoża rakkomandata ta' 5 mg kuljum, l-effetti mhux mixtieqa b'desloratadine kienu rrappurtati fi 3 %
English: In both studies, changes in exposure (AUC and Cmax) of desloratadine and 3-hydroxydesloratadine were not clinically relevant.
Maltese: Fiż-żewġ studji, il-bidliet fl-esponiment (AUC u Cmax) ta' desloratadine u ta' 3 hydroxydesloratadine ma kinux rilevanti b'mod kliniku.
English: In a multiple dose clinical trial, in which up to 20 mg of desloratadine was administered daily for 14 days, no statistically or clinically relevant cardiovascular effect was observed.
Maltese: Fi prova klinika b'ħafna dożi, li fiha sa 20 mg ta' desloratadine ngħataw kuljum għal 14-il ġurnata, ma ġie osservat l-ebda effett kardjovaskulari klinikament jew statistikament rilevanti.
English: Not known: frequency cannot be estimated from the available data - slow heartbeat, - change in the way the heart beats, - abnormal behaviour, - aggression.
Maltese: Mhux magħruf: il-frekwenza ma tistax tiġi stmata mid-dejta disponibbli - rata baxxa ta' taħbit tal-qalb, - bidla fil-mod kif tħabbat il-qalb, - imġiba mhux normali, - aggressjoni.
English: These symptoms include itching and hives.
Maltese: Kura tas-sintomi u ta' appoġġ hija rakkomandata.
English: Adults and adolescents (12 years of age and over) The recommended dose of Dasselta is one tablet once a day.
Maltese: Adulti u adolexxenti (minn 12-il sena 'l fuq)
English: The safety and efficacy of Dasselta 5 mg film-coated tablets in children below the age of 12 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Dasselta 5 mg pilloli miksija b'rita fit-tfal ta' inqas minn 12-il sena ma ġewx determinati s'issa.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Maltese: Tagħrif mhux kliniku bbażat fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il-ġeni, riskju ta' kanċer, effett tossiku fuq is-sistema riproduttiva u l-iżvilupp, ma juri l-ebda periklu speċjali għall-bnedmin.
English: Jaundice
Maltese: Pożoloġija
English: Desloratadine has been identified in breastfed newborns/infants of treated women.
Maltese: Leffett ta' desloratadine fit-trabi tat-twelid/trabi mhux magћruf.
English: In clinical studies with desloratadine, the following side effects were reported as:
Maltese: Fi studji kliniċi Fil-provi kliniċi b'desloratadine, l-effetti sekondarji li ġejjin kienu rrappurtati bħala:
English: - The other ingredients in the film-coating are: hypromellose (E464), macrogol, lactose monohydrate (see section 2 under »Dasselta contains lactose«.
Maltese: - Is-sustanzi l-oħra (l-eċċipjenti) tal-kisja tal-pillola huma: hypromellose, macrogol, lactose monohydrate (ara sezzjoni 2 taħt »Dasselta fih il-lattozju«), titanium dioxide (E171) u indigo carmine (E132).
English: Chronic idiopathic urticaria was studied as a clinical model for urticarial conditions, since the underlying pathophysiology is similar, regardless of etiology, and because chronic patients can be more easily recruited prospectively.
Maltese: Urtikarja idjopatika kronika kienet studjata bħala mudell kliniku għall-kundizzjonijiet tal-urtikarja, peress li l-patofiżjoloġija sottostanti hija simili, irrispettivament mill-etjoloġija, u peress li pazjenti kroniċi jistgħu jiġu rreġistrati aktar faċilment b'mod prospettiv.
English: Desloratadine was effective in alleviating the burden of seasonal allergic rhinitis as shown by the total score of the rhino-conjunctivitis quality of life questionnaire.
Maltese: Desloratadine kien effettiv biex iserraħ il-problemi relatati ma' rinite allerġika tal-istaġun kif jidher mill-punteġġ totali tal-kwestjonarju fuq il-kwalità tal-ħajja b'rinokonġuntivite.
English: Tachycardia, palpitations QT prolongation
Maltese: 6.3 Żmien kemm idum tajjeb il-prodott mediċinali
English: How to store Dasselta
Maltese: Twissijiet u prekawzjonijiet
English: In the case of severe renal insufficiency, Dasselta should be used with caution (see section 5.2).
Maltese: F'każ ta' insuffiċjenza renali severa, Dasselta għandu jintuża b'attenzjonii (ara sezzjoni 5.2).
English: 7 film-coated tablets: EU/1/11/739/001 10 film-coated tablets: EU/1/11/739/002 20 film-coated tablets: EU/1/11/739/003 30 film-coated tablets: EU/1/11/739/004 50 film-coated tablets: EU/1/11/739/005 90 film-coated tablets: EU/1/11/739/006 100 film-coated tablets: EU/1/11/739/007 250 film-coated tablets: EU/1/11/739/008
Maltese: EU/1/11/739/001 10 pilloli miksijin' b'rita:
English: No serious side effects are expected with accidental overdose.
Maltese: Mhux mistennija effetti kollaterali serji b'doża eċċessiva aċċidentali.
English: (see 4.3 Contraindications).
Maltese: (ara 4.3 Kontraindikazzjonijiet).
English: <Invented Name> provides 0.3 mmol/kg/d of magnesium when administered at maximum dose (see section 4.2).
Maltese: Numeta G16E jipprovdi 0.3 mmol/kg/d ta' manjeżju meta mogħti f'doża massima (ara sezzjoni 4.2).
English: The signs of hypermagnesaemia include generalised weakness, hypo-reflexia, nausea, vomiting, hypocalcaemia, respiratory failure, hypotension and arrhythmias.
Maltese: Is-sinjali ta' ipermanjeżemija jinkludu dgħjufija ġeneralizzata, iporiflessja, dardir, rimettar, ipokalkemija, indeboliment respiratorju, pressjoni baxxa u arritmiji.
English: Hypermagnesaemia
Maltese: SOMMARJU TAL-KARATTERISTIĊI
English: Summary of Product Characteristics of Numeta G16%E, and associated names
Maltese: TAL-PRODOTT ta' Numeta G16%E, u ismijiet assoċjati
English: Severe water and electrolyte equilibration disorders, severe fluid overload states, and severe metabolic disorders should be corrected before starting the infusion.
Maltese: Disturbi severi fl-ekwilibrazzjoni tal-ilma u tal-elettroliti, stati severi ta' tagħbija eċċessiva bi fluwidi, u disturbi metaboliċi severi għandhom jiġu kkoreġuti qabel il-bidu tal-infużjoni.
English: [This wording should be inserted at the end of the section]
Maltese: [Dan il-kliem għandu jiddaħħal fl-aħħar tas-sezzjoni]
English: Package Leaflet of Numeta G16%E, and associated names [This wording should be inserted at the top of the PL] This medicine is subject to additional monitoring.
Maltese: L-ammont ta' manjeżju f'Numeta G16%E, jista' jikkawża livelli għoljin ta' manjeżju fid-demm.
English: As signs of hypermagnesaemia may not be detected, monitoring of magnesium levels is advised at baseline and at appropriate intervals thereafter, in accordance with routine clinical practice and the needs of the individual patient.
Maltese: Minħabba li s-sinjali ta' ipermanjeżemija jistgħu ma jinkixfux, huwa rrakkommandat li jsir monitoraġġ tal-livelli tal-manjeżju fil-linja bażi u f'intervalli xierqa minn hemm 'il quddiem, skont il-prattika klinika ta' rutina u l-ħtiġijiet ta' kull pazjent.
English: Section 4.4 Special warnings and precautions for use Renal [This wording should be inserted]
Maltese: 4.4 Twissijiet speċjali u prekawzjonijiet għall-użu Renali
English: Fluid and electrolyte status including magnesium (see Hypermagnesaemia) should be closely monitored in these patients.
Maltese: L-istatus tal-fluwidi u tal-elettroliti inkluż tal manjeżju (ara Ipermanjeżemija) għandu jiġi mmonitorjat mill-qrib f'dawn il-pazjenti.
English: This is especially important in those patients at increased risk of developing hypermagnesaemia including patients with impaired renal function, patients receiving other medicinal products which place them at risk of developing hypermagnesaemia or patients receiving magnesium from other sources, including neonates whose mother's recently received magnesium in the antepartum period.
Maltese: Dan huwa importanti b'mod speċjali f'dawk il-pazjenti b'funzjoni tal-kliewi indebolita, pazjenti li jkunu qed jirċievu prodotti mediċinali oħrajn li jpoġġuhom f'riskju li jiżviluppaw ipermanjeżemija jew pazjenti li jirċievu lmanjeżju minn sorsi oħrajn, inkluż trabi tat-twelid li ommhom tkun għadha kif irċeviet il-manjeżju filperjodu ta' wara t-twelid.
English: Elevated levels of Magnesium in blood
Maltese: Livelli għoljin ta' Manjeżju fid-demm