FrancophonIA/ELRC3.0 huggingface dataset:
English: Experience in the younger adult population, including premenopausal women, is limited (see section 5.1).
Maltese: Hija limitata l-esperjenza fil-popolazzjoni ta' adulti mhux daqshekk kbar li tinkludi n-nisa qabel ilmenopawża (ara sezzjoni 5.1).
English: Premenopausal women with glucocorticoid-induced osteoporosis should be considered at high risk for fracture if they have a prevalent fracture or a combination of risk factors that place them at high risk for fracture (e.g., low bone density [e.g., T-score ≤−2], sustained high dose glucocorticoid therapy [e.g., ≥7.5 mg/day for at least 6 months], high underlying disease activity, low sex steroid levels).
Maltese: Nisa qabel il-menopawża b'osteoporożi kkawżata minħabba t-teħid ta' glukokortikojdi għandhom jiġu kkunsidrati li għandhom riskju għoli ta' ksur jekk diġà għandhom xi ksur jew għandhom taħlita ta' fatturi ta' riskju li jpoġġuhom f'riskju għoli li jkollhom xi ksur (eżempju densità ta' l-għadam baxx [eżempju valur T ≤ 2], terapija fit-tul ta' glukokortikojdi b'dożi għoljin [eżempju.> 7.5 mg/jum għallinqas għal 6 xhur], il-marda stess ta' l-osteoporożi hija attiva ħafna, il-livelli ta' l-isterojdi tassess huma baxxi).
English: Post-treatment management: Following treatment with teriparatide, 1,262 postmenopausal women from the pivotal trial enrolled in a post-treatment follow-up study.
Maltese: Wara l-kura b'teriparatide, 1,262 mara wara l-menopawża, mill-prova pivotali daħlu f'studju ta' wara l-kura.
English: Terrosa is used to treat osteoporosis in adults.
Maltese: Terrosa jintuża għall-kura ta' l-osteoporożi fl-adulti.
English: No medicine comes out of the needle during pen preparation step “G: Priming”.
Maltese: Ma toħroġx mediċina mil-labra waqt il-pass “G: Ipprajmjar” tat-tħejjija tal-pinna.
English: Do not use alcohol, other solvents or cleaning agents.
Maltese: Tużax alkoħol, solventi jew aġenti oħra tat tindif.
English: Terrosa 20 micrograms/80 microliters solution for injection Teriparatide
Maltese: Terrosa 20 mikrogramma/80 mikrolitri soluzzjoni għall-injezzjoni teriparatide
English: The pen and injection needles are not included with Terrosa.
Maltese: Il-pinna u l-labar tal-injezzjoni mhumiex inklużi ma' Terrosa.
English: The efficacy of teriparatide in men and women (N=428) receiving sustained systemic glucocorticoid therapy (equivalent to 5 mg or greater of prednisone for at least 3 months) was demonstrated in the 18month primary phase of a 36-month, randomised, double-blind, comparator-controlled study (alendronate 10 mg/day).
Maltese: Osteoporożi kkawżata minħabba t-teħid ta' glukokortikojdi L-effikaċja ta' teriparatide f'irġiel u nisa (N=428) li kienu qed jirċievu terapija bil-glukokortikojdi b'mod sistemiku fit-tul (ekwivalenti għal 5 mg jew iżjed ta' prednisone meħuda għallinqas għal 3 xhur) ġiet murija fl-ewwel fażi ta' 18-il xahar ta' studju double-blind, randomised, ikkontrollat b'komparatur (alendronate 10 mg/jum) u li dam 36 xahar.
English: At 36 months, analysis of spinal X-rays from 169 alendronate patients and 173 teriparatide patients showed that 13 patients in the alendronate group (7.7%) had experienced a new vertebral fracture compared with 3 patients in the teriparatide group (1.7%) (p=0.01).
Maltese: Wara 36 xahar, analiżi tal-X-rays tas-sinsla minn 169 pazjent fuq alendronate u minn 173 pazjent fuq teriparatide wrew li 13-il pazjent fil-grupp ta' alendronate (7.7 %) kellhom ksur wieħed vertebrali ġdid meta mqabbel ma' 3 pazjenti fil-grupp ta' teriparatide (1.7 %) (p=0.01). Barra minn hekk, 15 minn 214 il-pazjent fil-grupp ta' alendronate (7.0 %) esperjenzaw ksur wieħed mhux tal-vertebra meta mqabbel ma' 16 minn 214-il pazjent fil-grupp ta' teriparatide (7.5 %) (p=0.84).
English: Warnings
Maltese: Garanzija
English: • Put the Terrosa Pen, with the cartridge inserted, back into the refrigerator between 2 and 8 °C immediately after use.
Maltese: • Poġġi t-Terrosa Pen, bl-iskartoċċ imdaħħal, lura fil-friġġ bejn 2 u 8 °C immedjatament wara l-użu.
English: • spinning sensation
Maltese: • żieda fil-piż
English: BATCH NUMBER
Maltese: Numru tat-telefon:
English: Hypercholesterolaemia
Maltese: kolesterol fiddemm
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1159/001 [1 cartridge]
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/16/1159/001 [1 skartoċċ]
English: From a microbiological point of view, once opened, the product may be stored for a maximum of 28 days within its shelf life at 2 °C to 8 °C.
Maltese: Minn perspettiva mikrobijolġika ladarba nfetaħ, il-prodott jista' jinħażen għal massimu ta' 28 jum fi ħdan iż-żmien ta' kemm idum tajjeb f'temperatura ta' bejn 2°C u 8°C.
English: The pen can be used with compatible pen needles.
Maltese: labar tal-pinna kompatibbli.
English: In patients treated with teriparatide, lumbar spine, total hip and femoral neck BMD increased between 18 and 24 months by an additional 1.7%, 0.9%, and 0.4%, respectively.
Maltese: Bejn it-18 u l-24 xahar, fil-pazjenti kkurati b'teriparatide, ilBMD tal- parti lumbari tas-sinsla, tat-total tal-ġenbejn u tal-għonq femorali żdied b'1.7 %, b'0.9 % u b'0.4 % ieħor rispettivament.
English: Co-administration of raloxifene or hormone replacement therapy with teriparatide did not alter the effects of teriparatide on serum or urine calcium or on clinical adverse events.
Maltese: L-għotja ta' raloxifene jew terapija ta' sostituzzjoni ta' l-ormoni flimkien ma' teriparatide ma biddlitx l-effetti ta' teriparatide fuq calcium fis-serum jew fl-awrina jew fuq episodji avversi kliniċi.
English: Myalgia, arthralgia, back cramp/pain*
Maltese: uġigħ fis-sider, edima (l-iżjed periferali)
English: There is no specific antidote for teriparatide.
Maltese: M' hemmx antidotu speċifiku għal teriparatide.
English: Each cartridge contains 2.4 mL of solution, enough for 28 doses.
Maltese: Kull skartoċċ fih 2.4 mL ta' soluzzjoni li huma biżżejjed għal 28 doża.
English: • Screw the pen needle clockwise onto the cartridge holder.
Maltese: • Biċċa niedja hija biżżejjed biex tnaddaf it-Terrosa Pen.
English: Consult your doctor in the case of hearing or handling problems.
Maltese: Ikkonsulta t-tabib tiegħek f'każ ta' problemi ta' smigħ jew ta' maniġġ.
English: The warranty does not cover damages caused by:
Maltese: Il-garanzija ma tkoprix ħsarat ikkawżati minn:
English: All patients were offered 1000 mg calcium per day and 800 IU vitamin D per day.
Maltese: Il-pazjenti kollha ġew mogħtija 1,000 mg ta' calcium kuljum u 800 UI ta' vitamina D kuljum.
English: Terrosa cartridge and one carton of Terrosa Pen.
Maltese: Soluzzjoni għall-injezzjoni 1 Terrosa skartoċċ 1 Terrosa Pen
English: However, foetal resorption and reduced litter size occurred in pregnant rabbits administered daily doses of 3 to 100 micrograms/kg.
Maltese: Madankollu, fil-fniek tqal kien hemm assorbiment tal-fetu u tnaqqis fl-ammont ta' frieħ meta ngħataw dożi ta' 3 sa 100 mikrogramma/kg kuljum.
English: • low haemoglobin or red blood cell count (anaemia).
Maltese: • ammont baxx ta' emoglobina jew taċ-ċelluli ħomor fid-demm (anemija)
English: The dose knob cannot be turned clockwise up to the arrow sign.
Maltese: Madankollu, ma ġiex muri effett sinifikanti fuq ir-rata ta' ksur.
English: NAME OF THE MEDICINAL PRODUCT Terrosa 20 micrograms/80 microliters solution for injection teriparatide
Maltese: Informazzjoni għall-utent Terrosa 20 microgramma/80 mikrolitri soluzzjoni għall-injezzjoni Teriparatide
English: B: Remove the cartridge holder by turning it (bayonet coupling).
Maltese: B: Neħħi l-kontenitur tal-iskartoċċ billi ddawwru (agganċ bayonet).
English: Dizziness, headache, sciatica, syncope
Maltese: • nefħa l-iżjed fl-idejn, fis-saqajn u fir-riġlejn
English: The mean (median) vitamin D intake for the teriparatide arm was 1433 IU/day (1400 IU/day) and for the risedronate arm was 1191 IU/day (900 IU/day).
Maltese: Il-medja (medjan) tat-teħid tal-vitamina D għall-fergħa ta' teriparatide kienet 1,433 UI/kuljum (1,400
English: In this case continue with step “2.
Maltese: kompli b'pass “2.
English: There were no important effects observed in pregnant rats or mice administered teriparatide at daily doses of 30 to 1000 micrograms/kg.
Maltese: Ma pproduċa l-ebda effetti teratoġeniċi fil-firien, fil-ġrieden jew fil-fniek.Ma dehru ebda effetti importanti fil-firien u ġrieden tqal li ngħataw teriparatide f'dożi ta' 30 sa 1,000 mikrogramma/kg kuljum.
English: Subcutaneous use {1x} SC
Maltese: Ksur ta' fraġilità mhux vertebrali c
English: Urinary incontinence, polyuria, micturition urgency, nephrolithiasis
Maltese: Inkontinenza urinarja, tgħaddi ammont eċċessiv ta' awrina,
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 80 microliters contains 20 micrograms of teriparatide*.
Maltese: Kull doża ta' 80 mikrolitri fiha 20 mikrogramma ta' teriparatide*.
English: Dyspnoea
Maltese: Mistoqsija
English: If the instructions are not followed, there are risks of incorrect medication, inaccurate dosage, disease transmission or infection.
Maltese: Jekk ma jiġux segwiti listruzzjonijiet, hemm riskju ta' medikazzjoni inkorretta, dożaġġ mhux preċiż, trażmissjoni ta' mard jew infezzjoni.
English: Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture (see section 5.1).
Maltese: Kura ta' osteoporożi assoċjata ma' terapija b'glukokortikojdi sistemiċi meħuda fit-tul, fin-nisa u fl-irġiel li qegħdin f'riskju ogħla ta' ksur (ara sezzjoni 5.1).
English: - Metabolic bone diseases (including hyperparathyroidism and Paget's disease of the bone) other than primary osteoporosis or glucocorticoid-induced osteoporosis.
Maltese: minbarra l-osteoporożi primarja jew l-osteoporożi kkawżata mit-teħid tal-glukokortikojdi.
English: Glucocorticoid-induced osteoporosis
Maltese: • żieda fil-livell tal-kolesterol fid-demm
English: In an open-label study, 503 postmenopausal women with severe osteoporosis and a fragility fracture within the previous 3 years (83% had received previous osteoporosis therapy) were treated with teriparatide for up to 24 months.
Maltese: F'studju open-label, 503 nisa wara l-menopawża b'osteoporożi severa u li kellhom ksur ta' fraġilità fl- aħħar 3 snin (83 % kienu diġà rċevew kura għall-osteoporożi) ġew ikkurati b'teriparatide għal
English: • your Terrosa Pen with inserted cartridge
Maltese: Rimi ta' Terrosa Pen u u aċċessorji użati
English: The recommended dose is 20 micrograms (corresponding to 80 microliters) given once a day by injection under the skin (subcutaneous injection) in the thigh or abdomen.
Maltese: Id-doża rrakkmandata hija ta' 20 mikrogramma (li tikkorrispondi għal 80 mikrolitru) mogħtija darba kuljum b'injezzjoni taħt il-ġilda fil-koxxa jew fl-addome.
English: Do not repeat this before each daily injection, otherwise you will not have enough Terrosa for 28 days.
Maltese: Tirrepetix dan qabel kull injezzjoni ta' kuljum, inkella mhux se jkollok biżżejjed Terrosa għal 28 jum.
English: Terrosa must not be transferred to a syringe.
Maltese: Terrosa m'għandux jiġi ttrasferit għal siringa.
English: Elderly
Maltese: Murliti
English: Change the needle and repeat the priming as described in pen preparation sections “F” and “G”.
Maltese: Ibdel il-labra u rrepeti l-ipprajmjar kif deskritt fis-sezzjonijiet tat-tħejjija tal-pinna “F” u “G”.
English: Troubleshooting Follow the instructions given in the table if you have any questions regarding the use of Terrosa Pen:
Maltese: Segwi l-istruzzjonijiet mogħtija fit-tabella jekk għandek xi mistoqsijiet dwar l-użu ta' Terrosa Pen:
English: Nausea, vomiting, hiatus hernia, gastrooesophageal reflux disease
Maltese: Il-professjonisti tal-kura tas-saħħa huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata.
English: To prevent one or more new vertebral fractures, 11 women had to be treated for a median of 19 months.
Maltese: Biex jiġi evitat ksur waħdani jew aktar vertebrali ġdid, 11-il mara kellhom jiġu kkurati għal medja ta'
English: Renal failure/impairment
Maltese: Il-labra miksura/mgħawġa/mibruma.
English: At baseline, ninety percent of the patients had one or more vertebral fractures, and on average, vertebral BMD was 0.82 g/cm2 (equivalent to a T-score = - 2.6).
Maltese: Fil-linja bażi disgħin fil-mija tal-pazjenti kellhom ksur vertebrali waħdani jew aktar. u bħala medja l-BMD vertebrali kien ta' 0.82 g/cm² (ekwivalenti għal T-score = - 2.6)
English: Subcutaneous use.
Maltese: Madankollu,
English: 1 Terrosa Pen
Maltese: Għoti permezz tat-Terrosa Pen
English: Make sure that the pen needle is attached correctly and sits firmly on the cartridge holder.
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIRRIGWARD TAL-UŻU SIGUR U EFFETTIV TAL-PRODOTT
English: Teriparatide may cause small increases in urinary calcium excretion, but the incidence of hypercalciuria did not differ from that in the placebo-treated patients in clinical trials.
Maltese: ipercalciuria ma kinitx differenti minn dik fil-pazjenti kkurati bil-plaċebo fi provi kliniċi.
English: Fatigue, chest pain, asthenia, mild and transient injection site events, including pain, swelling, erythema, localised bruising, pruritus and minor bleeding at injection site
Maltese: Għeja, uġigħ fis sider, astenja, avvenimenti ħfief u momentanji fissit ta' l-injezzjoni, li jinkludu wġigħ,
English: Physiological actions of PTH include stimulation of bone formation by direct effects on bone forming cells (osteoblasts) indirectly increasing the intestinal absorption of calcium and increasing the tubular re-absorption of calcium and excretion of phosphate by the kidney.
Maltese: L-azzjonijiet fiżjoloġiċ i ta' PTH jikludu stimolu talformazzjoni ta' l-għadam permezz ta' effetti diretti fuq iċ-ċelloli li jiffurmaw l-għadam (osteoblasts) li jżidu indirettament l-assorbiment mill-intestin ta' calcium u li jżidu l-assorbiment mill-ġdid tubulari ta' calcium u l-eskrezzjoni ta' phosphate mill-kliewi.
English: Administration using the Terrosa Pen
Maltese: Ħażna u kura tat-Terrosa Pen
English: Terrosa 20 micrograms/80 microliters solution for injection: 1 or 3 cartridge(s) packed in a plastic tray sealed with lid foil and packed in a carton.
Maltese: Terrosa 20 mikrogramma/80 mikrolitru soluzzjoni għall-injezzjoni: skartoċċ wieħed jew 3 skrataċ.
English: Note: If the cartridge contains less than 80 microliters, the dose knob cannot be turned clockwise up to the arrow sign.
Maltese: Nota: Jekk l-iskartoċċ ikun fih inqas minn 80 mikrolitru, il-pum tad-doża ma jistax idur skont l-arloġġ sas-sinjal ta' vleġġa.
English: Re-attach pen cap
Maltese: Disturbi fil-qalb
English: Revasc contains the active substance desirudin.
Maltese: Revasc fih is-sustanza attiva desirudin.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) REVASC EPAR summary for the public
Maltese: RAPPORT TA' VALUTAZZJONI PUBBLIKA EWROPEW (EPAR) REVASC Sommarju ta' l-EPAR għall-pubbliku
English: The first injection should be started 5 to 15 minutes before surgery but after any anaesthesia.
Maltese: L-ewwel injezzjoni għandha tinbeda 5 sa 15-il minuta qabel il-kirurġija iżda wara kull anesteżija.
English: Desirudin, the active substance in Revasc, is nearly identical to hirudin, the anticoagulant substance produced by leeches.
Maltese: Desirudin, is-sustanza attiva f'Revasc, hija kważi identika għal hirudin, is-sustanza antikoagulanti prodotta mis-sangisugi.
English: The effectiveness of Revasc as an anticoagulant has been studied in four studies involving 1,621 patients who received Revasc.
Maltese: L-effikaċja ta' Revasc bħala antikoagulant ġiet studjata f'erba' studji li involvew 1,621 pazjent li rċevew Revasc.
English: The most common side effects with Revasc (seen in between 1 and 10 patients in 100) are anaemia (low red blood cell counts), nausea (feeling sick), wound secretion (oozing of fluid from wounds), hypotension (low blood pressure), deep thrombophlebitis (inflammation of deep veins that can be caused by a blood clot), fever, injection site mass (lumps at the site of injection), haematomas (collections of blood), oedema (swelling) in legs, and non-fatal allergic reactions.
Maltese: L-aktar effetti sekondarji komuni b'Revasc (li dehru f'madwar 1 u 10 pazjenti minn kull100) huma anemija (għadd baxx taċ-ċelloli ħomor tad-demm), nawżja (dardir), tnixxija mill-ferita (tnixxija ta' fluwidu mill-feriti), pressjoni baxxa, tromboflebite fonda (infjammazzjoni ta' vini fondi li tista' tkun ikkaġunata minn ċappa demm), deni, massa fis-sit ta' l-infezzjoni (għoqiedi fis-sit ta' l-infezzjoni), ematomi (kollezzjonijiet ta' demm), edima (nefħa) fir-riġlejn, u reazzjonijiet allerġiċi mhux fatali.
English: The recommended dose of Revasc is 15 mg twice daily.
Maltese: Id-doża irrakkomandata ta' Revasc hija 15 mg darbtejn kuljum.
English: Desirudin is produced by a method known as 'recombinant DNA technology': it is made by a yeast that has received a gene (DNA), which makes it able to produce the substance.
Maltese: Desirudin huwa magħmul b'metodu magħruf bħala ‘teknoloġija rikombinanti tad-DNA': huwa magħmul minn ħmira li tkun irċiviet ġene (DNA), li jagħmilha kapaċi tipproduċi s-sustanza.
English: Revasc was compared with unfractionated heparin or enoxaparin (other anticoagulants).
Maltese: Revasc tqabbel ma' l-eparina mhux frazzjonata jew enoxaparin (antikoagulanti oħra).
English: The marketing authorisation was renewed on 9 July 2002 and on 9 July 2007.
Maltese: L-awtorizzazzjoni għattqegħid fis-suq ġiet imġedda fid-9 ta' Lulju 2002 u fid-9 ta' Lulju 2007.
English: What is the risk associated with Revasc?
Maltese: X'inhu r-riskju assoċjat ma' Revasc?
English: Revasc is an anticoagulant; it prevents the blood from coagulating (clotting).
Maltese: Revasc huwa antikoagulant; huwa ma jħallix id-demm jikkoagula (jagħqad).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Revasc to Canyon Pharmaceuticals Limited on 9 July 1997.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea kollha, għal Revasc lil Canyon Pharmaceuticals Limited fid-9 ta' Lulju 1997.
English: It specifically blocks one of the substances involved in the clotting process, thrombin.
Maltese: Huwa speċifikament jimblokka waħda mis-sustanzi involuta fil-proċess tat-tagħqid tad-demm, thrombin.
English: How has Revasc been studied?
Maltese: Kif ġie studjat Revasc?
English: If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part
Maltese: Jekk trid aktar informazzjoni abbażi tar-rakkomandazzjonijiet ta' CHMP, aqra d-Diskussjoni Xjentifika (ukoll parti mill-EPAR).
English: The studies showed that desirudin was more effective than both comparator medicines in the prevention of deep vein thrombosis after hip replacement surgery.
Maltese: L-istudji wrew li desirudin kien aktar effettiv miż-żewġ mediċini li ġie kkumparat magħhom (comparator medicines) fil-prevenzjoni ta' trombożi tal-vini l-fondi wara kirurġija ta' sostituzzjoni talġenb.
English: For the full list of restrictions, see the Package Leaflet.
Maltese: Għal-lista sħiħa ta' restrizzjonijet, ara l-Fuljett ta' Tagħrif.
English: Revasc is intended to be given subcutaneously (under the skin), preferably in the abdomen (the tummy).
Maltese: Revasc huwa intenzjonat biex jingħata taħt il-ġilda, preferibbilment fl-addome (iż-żaqq).
English: The full EPAR for Revasc can be found here.
Maltese: Għaliex ġie approvat Revasc?
English: By using Revasc during and after hip or knee surgery, the risk of a blood clot forming in the blood vessels of the legs (deep vein thrombosis) is greatly reduced.
Maltese: Bl-użu ta' Revasc waqt u wara kirurgija tal-ġenb jew l-irkoppa, ir-riskju li tifforma ċappa demm fil-vini u l-arterji tad-demm tarriġlejn (trombożi tal-vini l-fondi) huwa ferm imnaqqas.
English: Parenteral route/IM-IV
Maltese: Rotta parenterali/IM-IV
English: Mivacurium and suxamethonium
Maltese: Mivacurium u suxamethonium
English: Tradename is an antiemetic.
Maltese: Tradename huwa antiemetiku.
English: Parenteral route
Maltese: Rotta parenterali
English: Over 60kg
Maltese: Aktar minn 60 kg 10 mg
English: Anticholinergics and morphine derivatives
Maltese: Antikolinerġiċi u derivati tal-morfina
English: Methaemoglobinemia
Maltese: Metaemoglobinemija
English: Metoclopramide increases cyclosporine bioavailability (Cmax by 46% and exposure by 22%).
Maltese: Metoclopramide jżid il-bijodisponibilità ta' cyclosporine (Cmax b'46% u esponiment b'22%).
English: Systeme Organ Class
Maltese: Is-Sistema tal-Klassifika tal-Organi
English: Strong CYP2D6 inhibitors
Maltese: Impedituri qawwija ta' CYP2D6
English: For tablets/capsules/granules
Maltese: Għal pilloli/kapsuli/granijiet
English: In adults patients
Maltese: F'pazjenti adulti
English: Do not exceed 3-month treatment because of the risk of involuntary muscle spasms.
Maltese: M'għandekx taqbeż 3 xhur ta' trattament minħabba r-riskju ta' spasmi involontarji tal-muskoli.
English: Central nervous system depressants (morphine derivatives, anxiolytics, sedative H1 antihistamines, sedative antidepressants, barbiturates, clonidine and related) Sedative effects of Central Nervous System depressants and metoclopramide are potentiated.
Maltese: Sedattivi tas-sistema nervuża ċentrali (derivati ta' morfina, ansjolitiċi, antihistamines sedattivi ta' HI, antidipressanti sedattivi, barbiturati, clonidine u mediċini relatati) L-effetti sedattivi ta' depressanti tas-Sisteema Nervuża Ċentrali u metoclopramide huma mħarrxa.
English: All indications (adult patients)
Maltese: L-indikazzjonijiet kollha (pazjenti adulti)
English: Methemoglobinemia which could be related to NADH cytochrome b5 reductase deficiency has been reported.
Maltese: Metaemoglobinemija li tista' tkun relatata ma' nuqqas ta' NADH cytochrome b5 reductase ġiet rapportata.
English: Uncontrollable movements (extrapyramidal disorders) may occur in children and young adults.
Maltese: Movimenti inkontrollabbli (disturbi ekstrapiramidali) jistgħu jseħħu fi tfal u adulti żgħar.
English: Frequencies are defined using the following convention: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000), very rare (<1/10000), not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma mfissra skont il-konvenzjoni li ġejja: komunu ħafna (≥1/10), komuni (≥1/100,<1/10), mhux komuni (≥1/1000, <1/100), rari (≥1/10000, <1/1000), rari ħafna (<1/10000), mhux magħruf (ma jistax jiġi stmat mit-tagħrif disponibbli).
English: Adverse reactions listed by System Organ Class.
Maltese: Ir-reazzjonijiet avversi huma elenkati fis-Sistema tal-Klassifika tal-Organi.
English: It contains a medicine called “metoclopramide”.
Maltese: Fih il-mediċina li tissejjah "metoclopramide".
English: - Use in children below 18 years of age
Maltese: 15-18 years
English: Rare (may affect up to 1 in 1,000 people) confusional state convulsion (especially in patients with epilepsy).
Maltese: Rari (tista' taffettwa sa persuna 1 f'1000) stat konfużjonali konvulsjoni (speċjalment f'pazjenti b'epilessija)
English: * Endocrine disorders during prolonged treatment in relation with hyperprolactinaemia (amenorrhoea, galactorrhoea, gynaecomastia).
Maltese: * Disturbi fis-sistema endokrinarja waqt trattament fit-tul fir-rigward ta' iperprolatinemija (amenorea, galatorea, ginekomastija)
English: Adults with liver problems
Maltese: Adulti bi problemi ta' kliewi
English: The clearance of metoclopramide is reduced by up to 70% in patients with severe renal impairment, while the plasma elimination half-life is increased (approximately 10 hours for a creatinine clearance of 10-50 mL/minute and 15 hours for a creatinine clearance <10 mL/minute).
Maltese: It-tneħħija ta' metoclopramide hija mnaqqsa sa 70% f'pazjenti b'indeboliment tal-kliewi sever, waqt li l-half-life ta' eliminazzjoni hi miżjuda (b'madwar 10 sigħat għal tneħħija tal-kreatinina ta' 10-50 mL/minuta u 15-il siegħa għal tneħħija ta' kreatinina < 10 mL/minuta).
English: The recommended single dose is 10 mg, repeated up to 3 times daily.
Maltese: Id-doża unika rakkomandata hi ta' 10 mg, ripetuta sa 3 darbiet kuljum.
English: All indications (paediatric patients aged 1-18 years)
Maltese: L-indikazzjonijiet kollha (pazjenti pedjatriċi minn 1-18-il sena)
English: Dosing table Age
Maltese: Tabella ta' dożaġġi Età
English: Serotonergic drugs
Maltese: Mediċini serotonerġiċi