FrancophonIA/ELRC3.0 huggingface dataset:
English: The onset time is ≤ 3 days post-zoledronic acid infusion, and the reaction is also referred to using the terms “flu-like” or “post-dose” symptoms.
Maltese: Iż-żmien ta' meta tibda huwa ≤3 ijiem wara l-infużjoni ta' zoledronic acid, u r-reazzjoni hija wkoll magħrufa bit-termini ta' sintomi “li jixbhu l-influwenza” jew “ta' wara d-doża”.
English: How Zoledronic Acid Accord is used
Maltese: Kif jintuża Zoledronic Acid Accord
English: Headache
Maltese: Nasofarinġite
English: How to store Zoledronic Acid Accord 6.
Maltese: Kif taħżen Zoledronic Acid Accord 6.
English: How Zoledronic Acid Accord is used 4.
Maltese: Kif jintuża Zoledronic Acid Accord 4.
English: dysgeusia,
Maltese: Wara d-dilwizzjoni:
English: Standard hypercalcaemia-related metabolic parameters, such as serum levels of calcium, phosphate and magnesium, should be carefully monitored after initiating zoledronic acid therapy.
Maltese: Ġiet irrapportata osteonekrożi tal-kanal estern tas-smigħ bil-bifosfonati, prinċipalment assoċjata ma' terapija fit-tul.
English: Episcleritis
Maltese: Osteonekrożi
English: • Painful redness and/or swelling of the eye.
Maltese: • Uġigħ fis-sider.
English: • Zoledronic Acid Accord must only be given by healthcare professionals trained in administering bisphosphonates intravenously, i.e. through a vein.
Maltese: • Zoledronic Acid Accord għandu jingħata biss minn professjonisti fil-kura tas-saħħa mħarrġa flgħoti ta' bisfosfonati ġol-vini, jiġifieri minn vina.
English: • Do not use Zoledronic Acid Accord after the expiry date stated on the pack.
Maltese: • Tużax Zoledronic Acid Accord wara d-data ta' skadenza li tidher fuq il-pakkett.
English: In a third phase III randomised, double-blind trial, zoledronic acid 4 mg or 90 mg pamidronate every 3 to 4 weeks were compared in patients with multiple myeloma or breast cancer with at least one bone lesion.
Maltese: III, 4 mg ta' zoledronic acid jew 90 mg ta' pamidronate, mogħtija kull 3 sa 4 gimgħat ġew imqabbla f'pazjenti b'maeloma multipla jew kanċer tas-sider li kellhom mill-inqas leżjoni waħdafl-għadam.
English: CLINICAL PARTICULARS 4.1 Therapeutic indications Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone.
Maltese: Prevenzjoni ta' problemi skelettriċi (ksur patoloġiku, kompressjoni tas-sinsla, radjazzjoni jew kirurġija fl-għadam, jew żieda fil-livell tal-kalċju fid-demm ikkawżat minn tumur) f'pazjenti adulti b'kanċer avanzat li jinvolvi l-għadam.
English: The active substance in Zoledronic Acid Accord is zoledronic acid, which belongs to a group of substances called bisphosphonates.
Maltese: Is-sustanza attiva f'Zoledronic Acid Accord hija zoledronic acid li jagħmel parti minn grupp ta' sustanzi li jissejħu bisfosfonati.
English: This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol ta' sodium (23 mg) f'kull kunjett, jiġifieri hija essenzjalment “ħielsa mis-sodju”.
English: • As a consequence of low calcium values: seizures, numbness and tetany (secondary to hypocalcaemia).
Maltese: • Bħala konsegwenza ta' valuri baxxi tal-kalċju: aċċessjonijiet, titrix u tetanja (kawża ta' ipokalċimija).
English: 6 PHARMACEUTICAL PARTICULARS
Maltese: 5. PROPRJETAJIET FARMAKOLOĠIĊI
English: Table 3: Efficacy results (solid tumours other than breast or prostate cancer) Any SRE (+TIH)
Maltese: Tabella 3: Riżultati li juru l-effikaċja (pazjenti b'tumuri solidi oħra barra dawk tas-sider u talprostata)
English: Currently available data are described in section 5.1 but no recommendation on a posology can be made.
Maltese: Dejta disponibbli hi deskritta fis-sezzjoni 5.1 imma l-ebda rakkomandazzjoni dwaril-pożoloġija ma tista' tingħata.
English: For storage conditions of the reconstituted solution for infusion, see section 6.3.
Maltese: Għall-kundizzjonijiet ta' ħażna tas-soluzzjoni rikostitwita għall-infużjoni, ara sezzjoni 6.3. 6.5
English: In the clinical studies, zoledronic acid treatment was resumed only when the creatinine level returned to within 10% of the baseline value (see section 4.4).
Maltese: Fi studji kliniċi, il-kura b'zoledronic acid reġgħet inbdiet biss meta l-livell ta' kreatinina kien reġa' ġie lura għal 10% tal-valur tal-linja bażi (ara sezzjoni 4.4).
English: To avoid potential incompatibilities, the infusion solution used for dilution must be either 0.9% w/v sodium chloride or 5% w/v glucose solution.
Maltese: Biex wieħed jevita inkompatibbiltajiet, is-soluzzjoni għall-infużjoni għandha tiġi ddilwita b'0.9% w/v sodium chloride jew b'5% w/v soluzzjoni ta' glucose.
English: • If you are being treated to reduce the amount of calcium in your blood, you will normally only be given one infusion of Zoledronic Acid Accord.
Maltese: • Jekk qed tingħata l-kura sabiex jitnaqqas l-ammont ta' kalċju fid-demm tiegħek, normalment tingħata biss infużjoni waħda ta' Zoledronic Acid Accord.
English: Treatment of TIH Adults and older people
Maltese: Kura ta' TIH Adulti u persuni anzjani
English: How to prepare and administer Zoledronic Acid Accord
Maltese: Kemm spiss jingħata Zoledronic Acid Accord
English: NR NR
Maltese: NUMRU(I)
English: Cases of osteonecrosis of the jaw have been reported, predominantly in cancer patients treated with medicinal products that inhibit bone resorption, such as zoledronic acid (see section 4.4).
Maltese: Każijiet ta' osteonekrożi (tax-xedaq) kienu rrappurtati, l-aktar f'pazjenti bil-kanċer ikkurati bi prodotti mediċinali li jinibixxu r-risorbiment tal-għadam, bħal zoledronic acid (ara sezzjoni 4.4).
English: Based on the review of both clinical trial and post-marketing cases, there is sufficient evidence to support an association between zoledronic acid therapy, the reported event of hypocalcaemia, and the secondary development of cardiac arrhythmia.
Maltese: L-istat ta' idratazzjoni tal-pazjenti għandu jiġi assessjat qabel u wara li jingħata Zoledronic Acid Accord, sabiex wieħed ikun ċert li l-pazjenti jkunu idratati kif jixraq.
English: Mean changes from baseline in BPI scores.
Maltese: • Livell baxx ta' manjesju u potassju fid-demm.
English: abdominal pain, dry mouth.
Maltese: Biex jintuża darba biss.
English: In multiple myeloma patients, the risk of renal dysfunction may be increased when zoledronic acid is used in combination with thalidomide.
Maltese: F'pazjenti b'maeloma multipla,ir-riskju ta' disfunzjoni tal-kliewi jista' jiżdied meta zoledronic acid jintuża flimkien ma' thalidomide.
English: • Low level of red blood cells (anaemia).
Maltese: • Livell baxx ta' ċelluli ħomor tad-demm (anemija).
English: • Low level of magnesium and potassium in the blood.
Maltese: • Biex tintuża darba biss.
English: I.V.
Maltese: MM MM
English: N Proportion of patients with SREs p-value Median time to SRE (days)
Maltese: Mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: Zoledronic acid is not recommended for patients presenting with severe renal impairment prior to initiation of therapy, which is defined for this population as CLcr < 30 ml/min.
Maltese: Zoledronic acid mhux irrakkomandat għall-pazjenti li jkollhom indeboliment sever tal-kliewi qabel tibda tterapija, li għal din il-popolazzjoni hi meqjusa bħala CLcr < 30 ml/min.
English: Withdrawals from treatment due to adverse events were similar with candesartan cilexetil/hydrochlorothiazide (2.3 - 3.3%) and placebo (2.7 - 4.3%)”.
Maltese: Irtirar mit-trattament minħabba episodji avversi kienu simili b'candesartan cilexetil/hydrochlorothiazide (2.3 - 3.3%) u bi plaċebo (2.7 - 4.3%)”.
English: The CHMP considered the following strengths for Atacand Plus tablets indicated for oral use: 8/12.5 mg, 16/12.5 mg, 32/12.5 mg, and 32/25 mg.
Maltese: 5 mg, 16/12.5 mg, 32/12.5 mg, u 32/25 mg.
English: Section 5.1 Pharmacodynamic Properties
Maltese: Sezzjoni 5.1 Tagħrif Farmakodinamiku
English: Atacand Plus contains candesartan cilexetil and hydrochlorothiazide (HCT).
Maltese: Atacand Plus fih candesartan cilexetil u hydrochlorothiazide (HCT).
English: This wording was considered in the proposed harmonised SPC.
Maltese: Din il-formolazzjoni tqieset fl-SPC armonizzat propost.
English: In particular, regarding interactions with potassium sparing diuretics, or other medicinal products that may increase serum potassium levels, other medicinal products that induce torsades de pointes, NSAIDS, colestipol or cholestyramine, nondepolarising skeletal muscle relaxants, calcium supplements or vitamin D, betablockers and diazoxide, anticholinergic agents, amantadine, cytotoxic medicinal products, alcohol intake, barbiturates, anaesthetics, antidiabetic medicinal products, pressor amines, iodinated contrast media and cyclosporine, among others.
Maltese: B'mod partikolari fir-rigward ta' interazzjonijiet ma' dijuretiċi li fihom ammont baxx ta' potassju, jew prodotti mediċinali oħrajn li jistgħu jżidu l-livelli ta' potassju fis-serum, prodotti mediċinali oħrajn li jinduċu torsades de pointes, NSAIDS, colestipol jew cholestyramine, rilassanti tal-muskoli skeletali li mhumiex depolarizzanti, supplimenti tal-kalċju jew vitamin D, beta-blockers u diazoxide, sustanzi antikolinerġiċi, amantadine, prodotti mediċinali ċitotossiċi, teħid ta' alkoħol, barbiturati, anestetiċi, prodotti mediċinali kontra d-dijabete, amini tat-tip pressor, mezzi ta' kuntrast bil-jodju u cyclosporine, fost oħrajn.
English: Warnings regarding renal impairment, kidney transplantation pregnancy, renal artery stenosis, intravascular volume depletion, anaesthesia and surgery, hepatic impairment, aortic and mitral valve stenosis, primary hyperaldosteronism, electrolyte imbalance, metabolic and endocrine effects, photosensitivity, pregnancy and others were harmonised.
Maltese: It-twissijiet fir-rigward ta' indeboliment tal-kliewi, trapjant tal-kliewi, tqala, stenożi tal-arterja talkliewi, tnaqqis fil-volum intravaskulari, anasteżija u kirurġija, indeboliment tal-fwied, stenożi talvalv tal-aorta u mitrali, aldosteroniżmu eċċessiv primarju, żbilanċ tal-elettrolit, effetti metaboliċi u endokrinali, sensittività għad-dawl, tqala u oħrajn ġew armonizzati.
English: • Pregnancy and lactation
Maltese: • Tqala u treddigħ
English: However, the CHMP/PhVWP report on the use of ACE inhibitors and angiotensin II receptor antagonists (ARBs) during the 1st trimester of pregnancy (EMEA/CHMP/PhVWP/474692/2007) indicates that a contraindication during the first trimester of pregnancy is not justified; the use of AIIRAs in the first trimester of pregnancy is not recommended.
Maltese: Madankollu, ir-rapport tas-CHMP/PhVWP dwar l-użu tal-inibituri tal-ACE u l-antagonisti tar-riċetturi ta' anġjotensina II (ARBs) matul l-ewwel trimestru tat-tqala (EMEA/CHMP/PhVWP/474692/2007) jindika li kontra-indikazzjoni matul l-ewwel trimestru tat-tqala mhijiex iġġustifikata; l-użu ta' AIIRAs fl-ewwel trimestru tat-tqala mhuwiex rakkomandat.
English: Candesartan cilexetil is an angiotensin receptor blocker (ARB).
Maltese: Candesartan cilexetil huwa imblokkatur tar-riċettur ta' anġjotensina (ARB).
English: Section 4.9 Overdose
Maltese: Sezzjoni 4.9 Doża Eċċessiva
English: The CHMP endorsed this updated information proposed by the MAH as harmonised text: “In controlled clinical studies with candesartan cilexetil/hydrochlorothiazide adverse reactions were mild and transient.
Maltese: Is-CHMP approva din linformazzjoni aġġornata proposta mill-MAH bħala test armonizzat: “Fi studji kliniċi kkontrollati b'candesartan cilexetil/hydrochlorothiazide, ir-reazzjonijiet avversi kienu ħfief u temporanji.
English: The CHMP endorsed the proposed harmonised wording: “The recommended dose of Atacand Plus is one tablet once daily.
Maltese: Is-CHMP awtorizza l-formulazzjoni armonizzata proposta: “Id-doża rakkomandata ta' Atacand Plus hija pillola waħda kuljum.
English: The sentence on the clinical significant interactions was corrected in line with the previous Atacand harmonisation referral.
Maltese: Is-sentenza dwar l-interazzjonijiet sinifikanti kliniċi ġiet ikkoreġuta skont referenza preċedenti ta' armonizzazzjoni ta' Atacand.
English: Dose titration with the individual components (candesartan cilexetil and hydrochlorothiazide) is recommended.
Maltese: It-titrazzjoni tad-doża bil-komponenti individwali (candesartan cilexetil u hydrochlorothiazide) hija rrakkomandata.
English: In line with the SPC Guideline (2009), two MSs included “Treatment of” followed by the indication.
Maltese: B'mod konformi mal-Linja gwida tal-SPC (2009), żewġ SMs inkludew “Trattament ta'” segwita bl-indikazzjoni.
English: All countries' SPCs for candesartan/HCT 16/12.5 mg or higher strengths included a recommendation on dose titration of candesartan before switching to the fixed dose combination.
Maltese: L-SPCs tal-pajjiżi kollha għal candesartan/HCT 16/12.5 mg jew iktar qawwijin inkludew rakkomandazzjoni dwar it-titrazzjoni tad-doża ta' candesartan qabel ma qelbu għall-kombinazzjoni ta' doża fissa.
English: Special populations
Maltese: TAL-PRODOTT IPPREŻENTATI
English: The approved mutual recognition wording stated “Essential hypertension, where monotherapy with candesartan cilexetil or hydrochlorothiazide is not sufficient.” There were some differences in Member States (MSs') summary of product characteristics' (SPCs) in the approved indication: most countries stated ‘Essential hypertension', one mentioned the word ‘arterial' (which was omitted in the final proposal), and one included the word ‘adult' (which was considered in the final proposal).
Maltese: Kien hemm xi differenzi f'sommarji tal-karatteristiċi tal-prodott (SPCs) ta' Stati Membri (SM) flindikazzjoni approvata: ħafna pajjiżi ddikjaraw ‘Pressjoni għolja essenzjali', wieħed semma' l-kelma ‘arterjali' (li ma kinitx inkluża fil-proposta finali) u ieħor inkluda l-kelma ‘adult' (li tqieset filproposta finali).
English: The information on administration of candesartan/HCT with or without food be located previously in section 4.5 was moved to section 4.2.
Maltese: L-informazzjoni dwar l-għoti ta' candesartan/HCT flimkien mal-ikel jew mhux mal-ikel, li qabel kienet tinsab fis-sezzjoni 4.5 tressqet għas-sezzjoni 4.2.
English: Section 4.8 Undesirable Effects
Maltese: Sezzjoni 4.8 Effetti Mhux Mixtieqa
English: Section 4.2 Posology and Method of Administration
Maltese: Sezzjoni 4.2 Pożoloġija u Metodu ta' kif jingħata
English: An additional sentence was introduced by CHMP to stress the preferable practice to titrate with separate components.
Maltese: Ġiet introdotta sentenza addizzjonali mis-CHMP sabiex jisħaq fuq il-prattika preferibbli li ssir titrazzjoni b'komponenti separati.
English: • the scope of the referral was the harmonisation of the summary of products characteristics, labelling and package leaflet
Maltese: • l-ambitu tar-referenza kien l-armonizzazzjoni tas-sommarju tal-karatteristiċi tal-prodotti, tikketta u fuljett ta' tagħrif
English: Furthermore, hydrochlorothiazide was omitted, as Atacand Plus contains hydrochlorothiazide.
Maltese: Barra minn hekk, hydrochlorothiazide tħalla barra minħabba li Atacand Plus fih hydrochlorothiazide.
English: The CHMP also agreed with the inclusion of a contraindication in patients with hypersensitivity to the active substances or to any of the excipients, severe renal and hepatic impairment and/or cholestasis, refractory hypokalaemia and hypercalcaemia, and gout.
Maltese: Is-CHMP qabel ukoll mal-inklużjoni ta' kontra-indikazzjoni f'pazjenti b'sensittività eċċessiva għassustanzi attivi jew għal xi sustanza attiva, indeboliment sever tal-kliewi u tal-fwied u/jew kolestażi, kalamija baxxa u għolja refrattorja u gotta.
English: The CHMP considered that the benefit/risk balance of candesartan cilexetil/hydrochlorothiazide is positive for the below mentioned indication and the proposed wording was supported and in line with current SPC guideline: “Treatment of essential hypertension, in adult patients whose blood pressure is not optimally controlled with candesartan cilexetil or hydrochlorothiazide monotherapy”.
Maltese: Is-CHMP qies li l-bilanċ bejn il-benefiċċju u r-riskju ta' candesartan cilexetil/hydrochlorothiazide huwa wieħed pożittiv għall-indikazzjoni msemmija hawn taħt u l-formolazzjoni tal-kliem proposta ġiet appoġġjata u kienet konformi mal-linja gwida attwali tal-SPC: “Kura ta' pressjoni għolja essenzjali, f'pazjenti adulti li l-pressjoni tad-demm tagħhom mhijiex ikkontrollata b'mod ottimali b'monoterapija ta' candesartan cilexetil jew ta' hydrochlorothiazide”.
English: Cough was added as a very rare ADR to section 4.8 of the SPC, as a result of the PSUR evaluation for candesartan/HCT.
Maltese: Is-sogħla żdiedet bħala ADR rari ħafna għal sezzjoni 4.8 tal-SPC, bħala konsegwenza tal-evalwazzjoni tal-PSUR għal candesartan/HCT.
English: Based on the information provided, the CHMP endorsed the harmonised text for the AIIRA as the standard warning elaborated by the CHMP's PhVWP for all AIIRA: the use of AIIRAs in the first trimester of pregnancy is not recommended; the use of AIIRAs in the second and third trimester is contraindicated.
Maltese: Fuq il-bażi tal-informazzjoni pprovduta, is-CHMP approva t-test armonizzat għall-AIIRA bħala ttwissija standard elaborata mill-PhVWP tas-CHMP għall-AIIRA kollha: l-użu tal-AIIRAs fl-ewwel trimestru tat-tqala mhuwiex rakkomandat; l-użu tal-AIIRAs fit-tieni u fit-tielet trimestru huwa kontraindikat.
English: When clinically appropriate a direct change from monotherapy to Atacand Plus may be considered.
Maltese: Meta jkun klinikament xieraq, tista' tiġi kkunsidrata bidla diretta minn monoterapija għal Atacand Plus.
English: The CHMP endorsed the harmonised text finding the proposed wording acceptable and in line with that of other ARB or antihypertensive SPCs.
Maltese: Is-CHMP approva t-test armonizzat u sab ilformulazzjoni proposta aċċettabbli u konformi ma' dik ta' ARB oħrajn jew ma' SPC kontra lpressjoni għolja oħrajn.
English: Dose titration of candesartan cilexetil is recommended when switching from hydrochlorothiazide monotherapy.
Maltese: It-titrazzjoni tad-doża ta' candesartan cilexetil hija rrakkomandata meta tinqeleb minn monoterapija b'hydrochlorothiazide.
English: The use of AIIRAs in the second and third trimester is contraindicated.
Maltese: L-użu ta' AIIRAs fit-tieni u fit-tielet trimestru huwa kontra-indikat.
English: Section 4.5 Interaction with Other Medicinal Products and Other Forms of Interaction
Maltese: Interazzjoni ma' Prodotti Mediċinali Oħrajn u Forom ta' Interazzjoni
English: This section was updated in accordance with the SPC Guideline (2009), including all ADRs listed in most countries, as the harmonised text.
Maltese: Din is-sezzjoni ġiet aġġornata skont il-Linja Gwida tal-SPC (2009), inkluż l-ADRs elenkati kollha f'ħafna mill-pajjiżi, skont it-test armonizzat.
English: • the summary of products characteristic, labelling and package leaflet proposed by the marketing authorisation holders have been assessed based on the documentation submitted and the scientific discussion within the Committee the CHMP has recommended the amendment of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for Atacand Plus and associated names (see Annex I).
Maltese: • is-sommarju tal-karatteristiċi tal-prodotti, tikketta u fuljett ta' tagħrif proposti mid-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq ġew evalwati fuq il-bażi tad-dokumentazzjoni sottomessa u tad-diskussjoni xjentifika fi ħdan il-Kumitat is-CHMP irrakkomanda l-emendar tal-awtorizzazzjonijiet għat-tqegħid fis-suq li s-sommarju talkaratteristiċi tal-prodotti, tikketta u fuljett ta' tagħrif għalihom huma stabbiliti fl-Anness
English: These subheadings in this section of the SPCs were revised in accordance with the SPC Guideline (2009).
Maltese: Dawn is-subintestaturi f'din is-Sezzjoni tal-SPCs ġew riveduti skont il-Linja gwida tal-SPC (2009).
English: The brief general safety information from clinical studies on doses up to 16/12.5 mg, including withdrawal figures was the same in most countries.
Maltese: L-informazzjoni fil-qosor dwar is-sigurtà ġenerali minn studji kliniċi fuq dożi ta' mhux aktar minn 16/12.5 mg, inkluż figuri ta' rtirar kienet l-istess f'ħafna mill-pajjiżi.
English: Section 4.6 Pregnancy and Lactation
Maltese: Sezzjoni 4.6 Tqala u Treddigħ
English: Atacand Plus may be administered in patients whose blood pressure is not optimally controlled with candesartan cilexetil or hydrochlorothiazide monotherapy or Atacand Plus at lower doses.
Maltese: Atacand Plus jista' jingħata lil pazjenti li l-pressjoni tad-demm tagħhom mhijiex ikkontrollata b'mod ottimali b'candesartan cilexetil jew b'monoterapija ta' hydrochlorothiazide jew Atacand Plus f'dożi iktar baxxi.
English: Please see Section 4.4 “Interference with laboratory testing”.
Maltese: Jekk jogħġbok ara Sezzjoni 4.4 “Interferenza mat-testijiet fil-laboratorju”.
English: Interference with laboratory testing
Maltese: Interferenza mat-testijiet fil-laboratorju
English: Sulfasalazine - Interference with dihydronicotinamideadenine dinucleotide / dihydronicotinamide-adenine dinucleotide phosphate (NADH/NADP) reaction assays (EPITT no 19351)
Maltese: Sulfasalazine - Interferenza ma' assaġġi tar-reazzjoni ta' dihydronicotinamide-adenine dinucleotide / dihydronicotinamide-adenine dinucleotide phosphate (NADH/NADP) (EPITT nru 19351)
English: Topiramate - Uveitis (EPITT no 19345)
Maltese: Topiramate - Uveite (EPITT nru 19345)
English: It is possible that alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatine kinase-muscle/brain (CK-MB), glutamate dehydrogenase (GLDH), or thyroxine may also show interference when sulfasalazine treatment is given at high doses.
Maltese: Huwa possibbli li alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatine kinase-muskolu/moħħ (CK-MB), glutamate dehydrogenase (GLDH), jew thyroxine jistgħu juru wkoll interferenza meta t-trattament b'sulfasalazine jingħata f'dożi għoljin.
English: Secukinumab - Dermatitis exfoliative generalised (EPITT no 19354)
Maltese: Secukinumab - Dermatite esfoljattiva ġeneralizzata (EPITT nru 19354)
English: Examples of such assays may include urea, ammonia, LDH, α-HBDH and glucose.
Maltese: Eżempji ta' tali assaġġi jistgħu jinkludu l-urea, l-ammonijaka, LDH, α-HBDH u l-glukożju.
English: Possible side effects Rare (may affect up to 1 in 1,000 people):
Maltese: Effetti sekondarji possibbli Rari (jistgħu jaffettwaw sa persuna 1 minn kull 1,000):
English: Temozolomide - Drug reaction with eosinophilia and systemic symptoms (DRESS) (EPITT no 19332)
Maltese: Temozolomide - Reazzjoni għall-mediċina b'esinofilja u sintomi sistemiċi (DRESS)(EPITT nru 19332)
English: Frequency not known: uveitis
Maltese: Frekwenza mhux magħrufa: uveite
English: Frequency ‘not known': Drug reaction with eosinophilia and systemic symptoms (DRESS)
Maltese: Frekwenza "mhux magħrufa": Reazzjoni għall-Mediċina b'esinofilja u sintomi sistemiċi (DRESS)
English: […] Overdose can unmask existing Brugada syndrome.
Maltese: […] Doża eċċessiva tista' tikxef is-sindromu eżistenti Brugada.
English: Propylthiouracil - Risk of congenital anomalies (EPITT no
Maltese: Propylthiouracil - Riskju ta' anomaliji konġenitali (EPITT nru 19358)
English: Loperamide - Brugada syndrome in the context of abuse with loperamide (EPITT no 19379)
Maltese: 1. Loperamide - Sindrome Brugada fil-kuntest ta' abbuż b'loperamide (EPITT nru 19379)
English: Sulfasalazine or its metabolites may interfere with ultraviolet absorbance, particularly at 340 nm, and may cause interference with some laboratory assays that use NAD(H) or NADP(H) to measure ultraviolet absorbance around that wavelength.
Maltese: Sulfasalazine jew il-metaboliti tiegħu jistgħu jinterferixxu mal-assorbiment ultravjola, b'mod partikolari fi 340 nm, u jistgħu jikkawżaw interferenza ma' xi assaġġi tal-laboratorju li jużaw NAD(H) jew NADP(H) biex ikejlu l-assorbiment ultravjola madwar dik il-frekwenza.
English: Rare: Exfoliative dermatitis 2) 2) Cases were reported in patients with psoriasis diagnosis
Maltese: Dermatite esfoljattiva 2) 2)
English: Fertility, pregnancy and lactation Women of childbearing potential
Maltese: Fertilità, tqala u treddigħ