FrancophonIA/ELRC3.0 huggingface dataset:
English: Mean (SD) serum total alkaline phosphatase activity was 459 (105) U/L at baseline and decreased to 369 (76) U/L at Week 64 (-19.6%, p < 0.0001).
Maltese: L-attività totali medja (SD) ta' alkaline phosphatase fis-serum kienet ta' 459 (105) U/L fil-linja bażi, u naqset għal 369 (76) U/L f'Ġimgħa 64 (-19.6%, p < 0.0001).
English: What is X-Linked Hypophosphataemia (XLH)
Maltese: X'inhi Ipofosfatimija X-Linked (XLH)
English: • People with XLH have higher levels of a hormone called fibroblast growth factor 23 (FGF23).
Maltese: (FGF23, fibroblast growth factor 23).
English: Polysorbate 80
Maltese: Polysorbate 80 L-methionine
English: Mean (SD) serum total alkaline phosphatase activity was 549 (193.8) U/L at baseline and decreased to 335 (87.6) U/L at Week 40 (mean change: -36.3%).
Maltese: L-attività totali medja (SD) ta'alkaline phosphatase fis-serum kienet ta' 549 (193.8) U/L fil-linja bażi, u naqset għal 335 (87.6) U/L f'Ġimgħa 40 (bidla medja: -36.3%).
English: Date of first authorisation: 19 February 2018 Date of latest renewal: 21 February 2019
Maltese: Data tal-aħħar tiġdid: 21 frar 2019
English: CRYSVITA 10 mg solution for injection CRYSVITA 20 mg solution for injection CRYSVITA 30 mg solution for injection burosumab
Maltese: IL-PRODOTT MEDIĊINALI CRYSVITA 10 mg soluzzjoni għall-injezzjoni CRYSVITA 20 mg soluzzjoni għall-injezzjoni CRYSVITA 30 mg soluzzjoni għall-injezzjoni
English: Each vial contains either 10, 20 or 30 mg of burosumab.
Maltese: Kull kunjett fih jew 10, 20 jew 30 mg ta' burosumab.
English: Toothache
Maltese: Pożoloġija
English: Each vial contains 45.91 mg sorbitol.
Maltese: Eċċipjent b'effett magħruf Kull kunjett fih 45.91 mg ta' sorbitol.
English: By inhibiting FGF23, burosumab increases tubular reabsorption of phosphate from the kidney and increases serum concentration of 1, 25 dihydroxy-Vitamin D.
Maltese: Billi jinibixxi FGF23, burosumab iżid l-assorbiment mill-ġdid tubulari tal-phosphate mill-kliewi, u jżid il-konċentrazzjoni ta' 1,25 dihydroxy-Vitamina D fis-serum.
English: In adult clinical trials no dose limiting toxicity has been observed using doses up to 1.0 mg/kg or a maximal total dose of 128 mg every 4 weeks.
Maltese: Fi provi kliniċi fuq l-adulti, ma ġiet osservata l-ebda tossiċità li tillimita d-doża bl-użu ta' dożi ta' sa 1.0 mg/kg jew doża totali massima ta' 128 mg kull 4 ġimgħat.
English: Shortening of the gestation period and associated increased incidence of premature births were observed in pregnant monkeys at doses of ≥ 0.3 mg/kg which corresponded to burosumab exposures that are ≥0.875- to 1.39-fold anticipated clinical levels.
Maltese: It-taqsir tal-perjodu ta' ġestazzjoni u żieda assoċjata fl-inċidenza ta' twelid prematuri, ġew osservati f'xadini tqal b'dożi ta' ≥ 0.3 mg/kg, li jikkorrispondu għal esponimenti ta' burosumab li huma ≥ 0.875 sa 1.39 darbiet tal-livelli kliniċi antiċipati.
English: In the reproductive and developmental toxicology study performed in pregnant cynomolgus monkeys, moderate mineralisation of the placenta was seen in pregnant animals given 30 mg/kg of burosumab and occurred in animals with peak serum phosphate concentration greater than approximately 2.58 mmol/L.
Maltese: Fl-istudju dwar tossikoloġija riproduttiva u tal-iżvilupp li twettaq f'xadini cynomolgus tqal, ġiet osservata mineralizzazzjoni moderata tal-plaċenta f'annimali tqal li ngħataw 30 mg/kg ta' burosumab, u seħħet f'annimali bl-ogħla konċentrazzjoni ta' phosphate fis-serum aktar minn madwar 2.58 mmol/L.
English: Pharmacotherapeutic group: Drugs for the treatment of bone diseases, other drugs affecting bone structure and mineralisation, ATC code: M05BX05.
Maltese: Mediċini għat-trattament ta' mard tal-għadam, mediċini oħrajn li jaffettwaw l-istruttura u l-mineralizzazzjoni tal-għadam, kodiċi ATC: M05BX05.
English: CRYSVITA is used to treat X-linked hypophosphataemia (XLH).
Maltese: CRYSVITA jintuża biex jittratta ipofosfatemija X-linked (XLH, X-linked hypophosphataemia).
English: Figure 1: Serum Phosphate Concentration (mmol/L) over Time in the Phase 2 Paediatric Study in Children 5-12 years Receiving Burosumab Every 2 Weeks (Q2W)
Maltese: Figura 1: Konċentrazzjoni tal-Phosphate fis-Serum (mmol/L) maż-Żmien fl-Istudju Pedjatriku ta' Fażi 2 fi Tfal Li Kellhom 5-12-il sena li Kienu Qed Jirċievu Burosumab Kull Ġimagħtejn (Q2W)
English: Burosumab has not been studied in patients with renal impairment.
Maltese: Burosumab ma ġiex studjat f'pazjenti b'indeboliment tal-kliewi.
English: This conventional therapy was discontinued 2-4 weeks prior to burosumab initiation.
Maltese: Din it-terapija konvenzjonali twaqqfet minn 2 sa 4 ġimgħat qabel il-bidu ta' burosumab.
English: Local reactions (e.g. injection site urticaria, erythema, rash, swelling, bruising, pain, pruritus, and haematoma) have occurred at the site of injection.
Maltese: Reazzjonijiet lokali (eż. urtikarja fis-sit tal-injezzjoni, eritema, raxx, nefħa, tbenġil, uġigħ, ħakk u ematoma) seħħew fis-sit tal-injezzjoni.
English: Radiographic Global Impression of Change (RGI-C) After 40 weeks of treatment with burosumab, the LS mean (SE) RGI-C Global score was +2.33 (0.08) in all 13 patients (p < 0.0001) demonstrating healing of rickets.
Maltese: Wara 40 ġimgħa ta' trattament bi burosumab, il-Punteġġ globali tal-medja ta' LS (SE) RGI-C kien ta' +2.33 (0.08) fit-13-il pazjent kollha (p<0.
English: The burosumab dose was adjusted to target a fasting serum phosphorous concentration of 1.13 to 1.62 mmol/L.
Maltese: Id-doża ta' burosumab ġiet aġġustata biex timmira konċentrazzjoni ta' phosphorus fis-serum waqt is-sawm ta' 1.13 sa 1.62 mmol/L.
English: Twenty six of 52 patients received burosumab every 4 weeks (Q4W).
Maltese: Sitta u għoxrin mit52 pazjent irċivew burosumab kull 4 ġimgħat (Q4W).
English: Bone changes were consistent with the pharmacology of burosumab and the role of phosphate in bone mineralization, metabolism and turnover.
Maltese: Il-bidliet fl-għadam kienu konsistenti mal-farmakoloġija ta' burosumab, u mar-rwol tal-phosphate fil-mineralizzazzjoni, il-metaboliżmu u t-turnover talgħadam.
English: Due to its molecular size, burosumab is not expected to be directly excreted.
Maltese: Minħabba d-daqs molekulari tiegħu, burosumab mhux mistenni li jitneħħa direttament.
English: In order to confirm the efficacy and safety of Crysvita in the treatment of X-linked Hypophosphataemia (XLH) in children between 1 and 12 years old, the MAH should conduct and submit the results of study UX023-CL301, a randomized, open-label, phase 3 Study to assess efficacy, safety and pharmacodynamics of the anti-FGF23 antibody, KRN23, versus oral phosphate and active vitamin D in paediatric patients with XLH.
Maltese: Sabiex tiġi kkonfermata l-effikaċja u s-sigurtà ta' Crysvita fit-trattament ta' Ipofosfatimija X-linked (XLH, X-linked Hypophosphataemia) fi tfal li jkollhom bejn sena u 12-il sena, l-MAH għandu jwettaq u jissottometti r-riżultati ta' studju UX023CL301, Studju ta' fażi 3, li fih il-parteċipanti ntgħażlu b'mod randomised, openlabel, biex jevalwa l-effikaċja, is-sigurtà u l-farmakodinamika tal-antikorp antiFGF23, KRN23, kontra phosphate orali u vitamina D attiva f'pazjenti pedjatriċi b'XLH.
English: CRYSVITA contains sorbitol This medicine contains 45.91 mg of sorbitol in each vial which is equivalent to 45.91 mg/ml.
Maltese: Din il-mediċina fiha 45.91 mg sorbitol f'kull kunjett li hu ekwivalenti għal 45.91 mg/mL.
English: Burosumab has been administered in paediatric clinical trials without dose limiting toxicity using doses up to 2.0 mg/kg body weight with a maximal dose of 90 mg every two weeks.
Maltese: Fil-provi kliniċi fuq pazjenti pedjatriċi, burosumab ġie amministrat b'doża mingħajr limitu ta' tossiċità minn dożi sa 2.0 mg/kg ta' piż talġisem b'doża massima ta' 90 mg kull ġimagħtejn.
English: Radiographic Global Impression of Change (RGI-C) As a complement to the RSS system to assess the severity of paediatric rickets in Study UX023CL201, the RGI-C is a relative rating scale that compares a patient's rickets before and after treatment utilising a 7-point ordinal scale to evaluate change in the same abnormalities rated in the RSS.
Maltese: RSS għall-evalwazzjoni tas--severità ta' rakitiżmu pedjatriku fi Studju UX023CL201, l-RGI-C hi skala ta' klassifikazzjoni relattiva li tqabbel ir-rakitimu ta' pazjent qabel u wara t-trattament, billi tuża skala ordinali ta' 7 punti biex tevalwa l-bidla fl-istess anormalitajiet li jkunu ġew ikklassifikati fl-RSS.
English: These effects were consistent with an exaggerated response to the inhibition of normal FGF23 levels resulting in a supraphysiologic increase in serum phosphate beyond the upper limit of normal.
Maltese: Dawn l-effetti kienu konsistenti ma' rispons esaġerat għall-inibizzjoni ta' livelli normali ta' FGF23, li rriżultaw f'żieda suprafiżjoloġika fil-phosphate fis-serum lil hinn mil-limitu ta' fuq tan-normal.
English: In paediatric Study UX023-CL205, burosumab was evaluated in 13 XLH patients, aged 1 to 4 years (mean 2.9 years; SD 1.1) for 40 weeks.
Maltese: Fi Studju UX023-CL205 fuq pazjenti pedjatriċi, burosumab ġie evalwat fi 13-il pazjent b'XLH, li kellhom minn 1 sa 4 snin (medja ta' 2.9 snin; SD 1.1) għal 40 ġimgħa.
English: In the group that received burosumab every 2 weeks, mean (SD) serum phosphate concentration increased from 0.77 (0.13) mmol/L at baseline, to 1.07 (0.13) mmol/L at Week 40 and was maintained to Week 64 at 1.08 (0.14) mmol/L.
Maltese: 77 (0.13) mmol/L fil-linja bażi, għal 1.07 (0.13) mmol/L f'Ġimgħa 40 u nżammet sa Ġimgħa 64 f'livell ta' 1.08 (0.14) mmol/L.
English: See section 4.8 for how to report adverse reactions.
Maltese: Ara sezzjoni 4.8 dwar kif għandu jiġu rappurtati reazzjonijiet avversi.
English: • FGF23 lowers the amount of phosphate in the blood.
Maltese: • FGF23 ibaxxi l-livell ta' phosphate fid-demm.
English: In repeat-dose toxicology studies of up to 40 weeks duration in cynomolgus monkeys, mineralisation of the rete testis/seminiferous tubules was observed in male monkeys; however, no changes were observed in semen analysis.
Maltese: Fl-istudji dwar it-tossikoloġija b'dożi ripetuti li damu sa 40 ġimgħa f'xadini cynomolgus, ġiet osservata mineralizzazzjoni tar-rete testis/seminiferous tubules f'xadini rġiel; madankollu, ma ġew osservati l-ebda bidliet fl-analiżi tal-isperma.
English: Burosumab increased serum phosphate concentration and increased TmP/GFR).
Maltese: Burosumab żied il-konċentrazzjoni tal-phosphate fis-serum, u żied TmP/GFR ( ratio of tubular maximum reabsorption of phosphate (TmP) to glomerular filtration rate, proporzjon tal-assorbiment massimu tubulari mill-ġdid tal-phosophate għar-rata tal-filtrazzjoni glomerulari).
English: The clearance of burosumab is dependent on body weight and estimated to be 0.290 L/day and 0.136 L/day in a typical adult (70 kg) and paediatric (30 kg) XLH patient, respectively, with corresponding disposition half-life (t1/2) in the serum of approximately 19 days.
Maltese: L/jum u 0.136 L/jum f'pazjent adult (70 kg) u f'pazjent pedjatriku (30 kg) tipiku b'XLH, rispettivament, b'half-life tad-dispożizzjoni korrispondenti (t1/2) fis-serum ta' madwar 19-il jum.
English: • you already have a high level of phosphate in your blood (“hyper-phosphataemia”)
Maltese: • diġà għandek livell għoli ta' phosphate fid-demm tiegħek (“iperfosfatimija”)
English: Vitamin D decreased
Maltese: Tnaqqis fil-vitamina D
English: The maximum volume of medicinal product per injection site is 1.5 ml.
Maltese: Il-volum massimu talprodott mediċinali f'kull sit tal-injezzjoni hu ta' 1.5 mL.
English: CRYSVITA 20 mg injection burosumab
Maltese: CRYSVITA 20 mg injezzjoni burosumab
English: CRYSVITA 30 mg injection burosumab
Maltese: CRYSVITA 30 mg injezzjoni burosumab
English: Burosumab was detected in serum from fetuses indicating that burosumab was transported across the placenta to the fetus.
Maltese: Burosumab instab fis-serum minn feti, u dan jindika li burosumab ġie ttrasportat mill-plaċenta għall-fetu.
English: With the subcutaneous route of administration, a direct PK-PD relationship between serum burosumab concentrations and increases in serum phosphate concentration is observed and well described by an Emax/EC50 model.
Maltese: Bir-rotta ta' għoti taħt il-ġilda, relazzjoni diretta PK-PD bejn il-konċentrazzjonijiet ta' burosumab fisserum u żidiet fil-konċentrazzjoni tal-phosphate fis-serum, huma osservati u deskritti tajjeb b' mudell Emax/EC50.
English: Fasting serum phosphate above the normal range for age due to the risk of hyperphosphatemia (see section 4.4).
Maltese: Phosphate fis-serum waqt is-sawm 'il fuq mill-medda normali għall-età minħabba riskju ta' iperfosfatimija (ara sezzjoni 4.4).
English: CRYSVITA 10 mg injection burosumab
Maltese: CRYSVITA 10 mg injezzjoni burosumab
English: Marketing Authorisation Holder Kyowa Kirin Holdings B.V. Bloemlaan 2
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Kyowa Kirin Holdings B.V.
English: Studies in animals have shown effects on male reproductive organs (see section 5.3).
Maltese: Studji f'annimali wrew effeti fuq l-organi riproduttivi tal-irġiel (ara sezzjoni 5.3).
English: • Toothache
Maltese: • Sturdament
English: In XLH patients, the observed volume of distribution of burosumab approximates the volume of plasma, suggesting limited extravascular distribution.
Maltese: F'pazjenti b'XLH, il-volum osservat tad-distribuzzjoni ta' burosumab iqarreb il-volum tal-plażma, li jissuġġerixxi distribuzzjoni extravaskulari limitata.
English: The severity of paediatric rickets in Study UX023-CL201 was measured using the RSS, a radiographic scoring method developed originally to assess the severity of nutritional rickets in the wrists and knees based on the degree of metaphyseal fraying, concavity, and the proportion of the growth plate affected.
Maltese: Is-severità tar-rakitiżmu f'pazjenti pedjatriċi fi Studju UX023-CL201 tkejlet bl-użu ta' RSS, metodu ta' punteġġ radjografiku żviluppat oriġinarjament biex jevalwa s-severità tar-rakitiżmu nutrizzjonali fil-polz u fl-irkupptejn ibbażati fuq id-dgħufija (fraying) tal-metaphysis, il-konkavità, u l-proporzjon tal-growth plate affettwata.
English: In Study UX023-CL201, the RSS was scored using a predefined scale looking at specific abnormalities in the wrists and knees.
Maltese: Fi Studju UX023-CL201, l-RSS ingħata punteġġ bl-użu ta' skala definita minn qabel li tħares lejn anormalitajiet speċifiċi fl-polz u fl-irkupptejn.
English: (See “CRYSVITA contains sorbitol” in section 2 for more information).
Maltese: (Ara “CRYSVITA fih is-sorbitol” f'sezzjoni 2 għal aktar informazzjoni.
English: In paediatric Study UX023-CL201, 52 paediatric patients aged 5 to 12 years (mean 8.5 years; SD 1.87) with XLH were treated for 64 weeks.
Maltese: Fi Studju UX023-CL201 fuq pazjenti pedjatriċi, 52 pazjent pedjatriku li minn 5 sa 12-il sena (medja ta' 8.5 snin;
English: This being a conditional marketing authorisation and pursuant to Article 14(7) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures: Description
Maltese: Peress li din hi Awtorizzazzjoni għat-Tqegħid fis-Suq kondizzjonali u skont l-Artikolu 14(7) tarRegolament (KE) 726/2004, l-MAH għandu jtemm, fiż-żmien stipulat, il-miżuri li gejjin:
English: After 40 weeks of treatment with burosumab, mean total RSS improved from 2.92 (1.367) at baseline to 1.19 (0.522), corresponding to a change from baseline in LS mean (SE) change of -1.73 (0.132) (p<0.0001).
Maltese: Punteġġ tas-Severità tar-Rakitiżmu (RSS, Rickets Severity Score) Wara 40 ġimgħa ta' trattament bi burosumab, il-medja totali ta' RSS tjiebet minn 2.92 (1.367) fil-linja bażi, għal 1.19 (0.522), li jikkorrispondi għal bidla mil-linja bażi fil-bidla fil-medja ta' LS (SE) ta' -1.73 (0.132) (p<0.
English: What CRYSVITA is
Maltese: X'inhu CRYSVITA
English: In order to confirm the efficacy and safety of Crysvita in the treatment of X-linked Hypophosphataemia (XLH) in children between 1 and 4 years old, the MAH should submit the updated results of study UX023-CL205, an open-label, phase 2 study to assess the safety, pharmacodynamics, and efficacy of KRN23 in paediatric patients with XLH.
Maltese: Sabiex tiġi kkonfermata l-effikaċja u s-sigurtà ta' Crysvita fit-trattament ta' Ipofosfatimija X-linked (XLH, X-linked Hypophosphataemia) fi tfal li jkollhom bejn sena u 4 snin, l-MAH għandu jissottometti r-riżultati aġġornati ta' studju UX023CL205, studju ta' fażi 2, open-label, biex jevalwa s-sigurtà, il-farmakodinamika u leffikaċja ta' KRN23 f'pazjenti pedjatriċi b'XLH.
English: Concurrent administration of burosumab with oral phosphate and vitamin D analogues is contraindicated as it may cause an increased risk of hyperphosphatemia and hypercalcaemia (see section 4.3).
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni L-għoti fl-istess ħin ta' burosumab ma' phosphate orali u analogi ta' vitamina D hu kontraindikat għax jista' jikkawża żieda fir-riskju ta' iperfosfatimija u iperkalċimija (ara sezzjoni 4.3).
English: Study UX023-CL201
Maltese: Studju UX023-CL201
English: The recommended starting dose is 0.4 mg/kg of body weight and the normal maintenance dose is 0.8 mg/kg burosumab given every two weeks.
Maltese: Id-doża tal-bidu hija rakkomandata hija ta' 0.4 mg/kg ta' piż tal-ġisem u d-doża ta' manteniment normali hija ta' 0.8 mg/kg ta' burosumab li tingħata kull ġimagħtejn.
English: Study UX023-CL205
Maltese: Studju UX023-CL205
English: Dose interruption and/or dose reduction may be required (see section 4.2).
Maltese: L-interruzzjoni u/jew tnaqqis fid-doża jista' jkun meħtieġ (ara sezzjoni 4.2).
English: All 13 patients were considered RGI-C responders as defined by RGI-C global score ≥ +2.0.
Maltese: It-13-il pazjenti kollha kienu kkunsidrati li rrispondew għal RGI-C kif definit mill-punteġġ globali
English: 20 mg CARTON
Maltese: Ż-ŻGĦAR EWLENIN 20 mg KUNJETT
English: Missed dose
Maltese: Żieda fid-doża
English: • medicines that work in the same way as calcium in the body (“calcimimetics”).
Maltese: • mediċini li jaħdmu bl-istess mod bħal calcium fil-ġisem (“kalċimimetiċi”).
English: X-Linked Hypophosphataemia (XLH) is a genetic disease.
Maltese: Ipofosfatimija X-Linked (XLH) hi marda ġenetika.
English: Burosumab displays time-invariant pharmacokinetics that is linear to dose over the subcutaneous dose range of 0.1 to 2.0 mg/kg.
Maltese: Burosumab juri farmakokinetika ta' li ma tvarjax maż-żmien li hi lineari mad-doża fuq il-medda taddoża taħt il-ġilda doża ta' 0.1 sa 2.0 mg/kg.
English: If fasting serum phosphate is below the reference range for age, the dose may be increased stepwise by 0.4 mg/kg up to a maximum dose of 2.0 mg/kg (maximum dose of 90 mg).
Maltese: Jekk il-phosphate fis-serum waqt is-sawm ikun taħt il-medda ta' referenza għall-età, id-doża tista' tiżdied f'inkrementi b'0.4 mg/kg sa doża massima ta' 2.0 mg/kg (doża massima ta' 90 mg).
English: How to store CRYSVITA
Maltese: X'fih CRYSVITA
English: (positive indicates healing)
Maltese: (pożittiv jindika fejqan)
English: Monitoring of urine calcium and phosphate is suggested every 3 months.
Maltese: Il-monitoraġġ tal-calcium u l-phosphate fl-awrina hu ssuġġerit kull 3 xhur.
English: 30 mg CARTON
Maltese: Ż-ŻGĦAR EWLENIN 30 mg KUNJETT
English: Serum burosumab and phosphate concentrations, as well as TmP/GFR, increased and decreased in parallel and reached maximum levels at approximately the same time point after each dose, supporting a direct PK-PD relationship.
Maltese: Il-konċentrazzjonijiet tal-burosumab u tal-phosphate fis-serum kif ukoll it-TmP/GFR, żdiedu u naqsu b'mod parallel, u laħqu livelli massimi bejn wieħed u ieħor fl-istess punt ta' żmien wara kull doża, u dan jappoġġja relazzjoni PK-PD diretta.
English: The peak serum concentration (Cmax) and area under the concentration-time curve (AUC) of serum burosumab is dose proportional over the dose range of 0.1-2.0 mg/kg.
Maltese: L-ogħla konċentrazzjoni fis-serum (Cmax) u l-erja taħt il-kurva tal-ħin-konċentrazzjoni (AUC) ta' burosumab fis-serum hu proporzjonali għad-doża fuq ilmedda tad-doża ta' 0.
English: To decrease the risk for ectopic mineralisation, it is recommended that fasting serum phosphate is targeted in the lower end of the normal reference range for age (see section 4.4).
Maltese: Biex tnaqqas ir-riskju għal mineralizzazzjoni ektopika, hu rakkomandat li l-phosphate fis-serum waqt is-sawm ikollu mira fit-tarf t'isfel tal-medda normali ta' referenza għall-età (ara sezzjoni 4.4).
English: • severe swelling of eyelids, mouth or lips (angio-oedema)
Maltese: • Uġigħ fil-muskoli (majalġja) u fl-idejn u fis-saqajn
English: CRYSVITA 20 mg solution for injection
Maltese: CRYSVITA 20 mg soluzzjoni għall-injezzjoni
English: Monitoring of plasma alkaline phosphatases, Calcium, PTH and creatinine is recommended every 6 months (every 3 months for children 1- 2 years) or as indicated.
Maltese: Il-monitoraġġ ta' plażma alkaline phosphatases, calcium, ormon tal-paratirojde (PTH, parathyroid hormone) u kreatinina, hu rakkomandat kull 6 xhur (kull 3 xhur fi tfal li jkollhom bejn sena u sentejn) jew kif indikat.
English: If you could get pregnant, you must use an effective method of contraception (birth control) while using CRYSVITA.
Maltese: Jekk inti tista' toħroġ tqila, inti trid tuża metodu effettiv ta' kontraċezzjoni (birth control) waqt li tkun qed tuża CRYSVITA.
English: You may get skin reactions where the injection is given, see section 4 for more information.
Maltese: Tista' tiżviluppa reazzjonijiet tal-ġilda fejn tingħata l-injezzjoni; ara sezzjoni 4 għal aktar informazzjoni.
English: CRYSVITA 30 mg solution for injection
Maltese: CRYSVITA 30 mg soluzzjoni għall-injezzjoni
English: Nearly all patients had radiographic evidence of rickets at baseline and had received prior oral phosphate and vitamin D analogues for a mean (SD) duration of 7 (2.4) years.
Maltese: Kważi l-pazjenti kollha kellhom evidenza radjografika ta' rakitiżmu (rickets) fil-linja bażi, u kienu rċivew phosphate orali u analogi ta' vitamina D qabel, għal tul ta' żmien medju (SD) ta' 7 (2.4) snin.
English: L-histidine
Maltese: IL-ĠERMANJA
English: Ectopic mineralisation of multiple tissues and organs (e.g. kidney, heart, lung, and aorta), and associated secondary consequences (e.g. nephrocalcinosis) in some cases, due to hyperphosphataemia, was observed in normal animals at doses of burosumab that resulted in serum phosphate concentrations in animals greater than approximately 2.58 mmol/L.
Maltese: Studji fil-fniek u f'xadini cynomolgus adulti u żgħar, urew żidiet tal-phosphate fis-serum u 1,25 (OH)2D li jiddependu mid-doża li jikkonfermaw l-azzjonijiet farmakoloġiċi ta' burosumab f'dawn lispeċi. Mineralizzazzjoni ektopika ta' tessuti u organi multipli (eż. kliewi, qalb, pulmun, u aorta), u lkonsegwenzi sekondarji assoċjati (eż. nefrokalċinożi) f'ċerti każijiet, minħabba iperfosfatimija, ġew osservati f'annimali normali b'dożi ta' burosumab li rriżultaw f'konċentrazzjonijiet ta' phosphate fisserum fl-annimali li kienu aktar minn madwar 2.58 mmol/L.
English: Each vial contains 20 mg burosumab in 1 ml of solution.
Maltese: Kull kunjett fih 20 mg ta' burosumab f'1 ml ta' soluzzjoni.
English: Burosumab must be discontinued if serious hypersensitivity reactions occur and appropriate medical treatment should be initiated.
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIR-RIGWARD TAL-UŻU SIGUR U EFFETTIV TAL-PRODOTT MEDIĊINALI
English: Patients received burosumab at a dose of 0.8 mg/kg every two weeks.
Maltese: Il-pazjenti kienu rċivew burosumab f'doża ta' 0.8 mg/kg kull ġimagħtejn.
English: All patients had radiographic evidence of rickets at baseline and twelve patients had received oral phosphate and vitamin D analogues for a mean (SD) duration of 16.7 (14.4) months.
Maltese: Il-pazjenti kollha kellhom evidenza radjografika ta'rakitiżmufil-linja bażi, u tnax-il pazjent kienu rċivew phosphate orali u analogi ta' vitamina D, għal tul ta' żmien medju (SD) ta' 16.7 (14.4) xhur.
English: 10 mg CARTON
Maltese: Ż-ŻGĦAR EWLENIN 10 mg KUNJETT
English: Each vial contains 30 mg burosumab in 1 ml of solution.
Maltese: Kull kunjett fih 30 mg ta' burosumab f'1 ml ta' soluzzjoni.
English: There are no clinical data available on the effect of burosumab on human fertility.
Maltese: M'hemm l-ebda data klinika disponibbli dwar l-effett ta' burosumab fuq il-fertilità tal-bniedem.