FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, enzymes, ATC code: A16AB13
Maltese: Prodotti oħrajn għall-passaġġ tal-ikel u tal-metaboliżmu, enzimi, Kodiċi ATC:
English: Each vial contains 18 mg of asfotase alfa (18 mg/0.45 ml).
Maltese: Kull kunjett fih 18 mg ta' asfotase alfa (18 mg/0.45 ml).
English: At Week 48, 50/69 patients (72.5%) in the full analysis set achieved Radiographic Global Impression of
Maltese: F'Ġimgħa 48, 50/69 (72.5%) fis-sett sħiħ ta' analiżi kisbu punteġġi fir-Radiographic Global Impression of Change ta' ≥ 2, u kienu kkunsidrati bħala individwi li wrew rispons.
English: Age at treatment initiation in the study was between 0.5 to 35 months.
Maltese: L-età fil-bidu tal-kura fl-istudju kienet ta' bejn 0.5 u 35 xahar.
English: Hypersensitivity reactions including signs and symptoms consistent with anaphylaxis have been reported in patients treated with asfotase alfa (see section 4.8).
Maltese: Reazzjonijiet ta' sensittività eċċessiva li jinkludu sinjali u sintomi konsistenti ma' anafilassi ġew irrappurtati f'pazjenti ttrattati b'asfotase alfa (ara sezzjoni 4.8).
English: Headache
Maltese: Dożaġġ
English: Craniosynostosis as a manifestation of hypophosphatasia is documented in published literature and occurred in 61.3% of patients between birth and 5 years of age in a natural history study of untreated infantile-onset hypophosphatasia patients.
Maltese: Kranjosinostożi, bħala manifestazzjoni ta' ipofosfatasija, hi ddokumentata fil-letteratura ppubblikata u seħħet f'61.3% tal-pazjenti bejn it-twelid sa meta kellhom 5 snin fi studju ta' storja naturali ta' pazjenti b'ipofosfatasija li bdiet fi żmien it-tfulija, mhux ittrattati.
English: Asfotase alfa, a human recombinant tissue-nonspecific alkaline phosphatase-Fc-deca-aspartate fusion protein with enzymatic activity, promotes mineralisation of the skeleton in patients with hypophosphatasia.
Maltese: Asfotase alfa, proteina tal-fużjoni alkaline phosphatase-Fc-deca-aspartate mhux speċifiku għat-tessut rikombinanti uman b'attività enzimatika, tippromwovi l-mineralizzazzjoni tal-iskeletru f'pazjenti b'ipofosfatasija.
English: Light blue
Maltese: Blu ċar
English: Strensiq 40 mg/ml solution for injection (12 mg/0.3 ml 18 mg/0.45 ml 28 mg/0.7 ml 40 mg/1 ml) asfotase alfa
Maltese: Strensiq 40 mg/ml soluzzjoni għall-injezzjoni (12 mg/0.3 ml 18 mg/0.45 ml 28 mg/0.7 ml 40 mg/1 ml) asfotase alfa
English: At last assessment (n = 10, 9 of whom had at least 72 months of treatment), median Z-score improvements from baseline were 1.93 for length/height and 2.43 for weight.
Maltese: Fl-aħħar evalwazzjoni (n = 10, li 9 minnhom ġew ikkurati għal mill-inqas 72 xahar), it-titjib tal-punteġġ-Z medjan mil-linja bażi kien 1.93 għat-tul/għoli u 2.43 għall-piż.
English: Each vial contains 40 mg of asfotase alfa (40 mg/1 ml).
Maltese: Kull kunjett fih 40 mg ta' asfotase alfa (40 mg/1 ml).
English: Based on the results of population pharmacokinetic analysis it was concluded that asfotase alfa exhibits linear pharmacokinetic up to subcutaneous doses of 28 mg/kg/week.
Maltese: Ibbażat fuq ir-riżultati ta' analiżi farmakokinetika tal-popolazzjoni, ġie konkluż li asfotase alfa juri farmakokinetika lineari sa dożi taħt il-ġilda ta' 28 mg/kg/ġimgħa.
English: The impact of immunogenicity on asfotase alfa pharmacokinetic varied over time due to the time varying nature of immunogenicity and overall was estimated to decrease pharmacokinetic exposures by less than 20%.
Maltese: L-impatt tal-immunoġeniċità fuq il-farmakokinetika ta' asfotase alfa varja maż-żmien minħabba n-natura tal-immunoġeniċità li varjat maż-żmien, u globalment ġiet stmata li tnaqqas l-esponimenti farmakokinetiċi b'inqas minn 20%.
English: Strensiq 100 mg/ml solution for injection (80 mg/0.8 ml) asfotase alfa
Maltese: Strensiq 100 mg/ml soluzzjoni għall-injezzjoni (80 mg/0.8 ml) asfotase alfa
English: Each vial contains 28 mg of asfotase alfa (28 mg/0.7 ml).
Maltese: Kull kunjett fih 28 mg ta' asfotase alfa (28 mg/0.7 ml).
English: For the time period of observation of historical controls: 1/16 patients displayed apparent catch-up heightgain, 12/16 patients did not display apparent catch-up height-gain and data were inconclusive in 3/16 patients.
Maltese: Għall-perjodu ta' żmien ta' osservazzjoni ta' kontrolli storiċi: 1/16-il pazjent urew żieda fit-tul catch-up apparenti, 12/16-il pazjent ma wrewx żieda fit-tul catch-up apparenti, u d-data ma kinitx konklużiva fi 3/16-il pazjent.
English: Sodium phosphate dibasic heptahydrate Sodium phosphate monobasic monohydrate Water for injections
Maltese: Sodium phosphate monobasic monohydrate
English: Injection site reactions (including injection site atrophy, abscess, erythema, discolouration, pain, pruritus, macule, swelling, contusion, bruising, lipodystrophy (lipoatrophy or lipohypertrophy), induration, reaction, nodule, rash, papule, haematoma, inflammation, urticarial, calcification, warmth, haemorrhage,
Maltese: Reazzjonijiet fis-sit tal-injezzjoni (li jinkludu atrofija, axxess, eritema fis-sit tal-injezzjoni, tibdil fil-kulur, uġigħ, ħakk, makula, nefħa, kontużjoni, tbenġil, lipodistrofija (lipoatrofija jew lipoipertrofija), ebusija, reazzjoni, għoqda, raxx, bżieżaq żgħar, ematoma, infjammazzjoni, urtikarja, kalċifikazzjoni, sħana, emorraġija, ċellulite, ċikatriċi, massa, estravażazzjoni, esfoljazzjoni u vexxikuli) huma l-aktar reazzjonijiet avversi komuni osservati f'madwar 74% tal-pazjenti fil-provi kliniċi.
English: Height, weight and head circumference were plotted on growth charts (series of percentile curves that illustrate distribution) available from the Centers for Disease Control and Prevention (CDC), USA.
Maltese: It-tul, il-piż u ċ-ċirkonferenza tar-ras tpinġew fuq ċarts tat-tkabbir (serje ta' kurvi ta' perċentili li juru ddistribuzzjoni) disponibbli mis-Centers for Disease Control and Prevention, USA.
English: Patients should be monitored for recurrence of signs and symptoms of a severe hypersensitivity reaction.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati għar-rikorrenza ta' sinjali u sintomi ta' reazzjoni ta' sensittività eċċessiva.
English: Based on its structure and pharmacokinetics, asfotase alfa is unlikely to affect Cytochrome P-450 related metabolism.
Maltese: Ibbażat fuq l-istruttura u l-farmakokinetika tiegħu, asfotase alfa mhuwiex probabbli li jaffettwa l-metaboliżmu relatat ta' ċitokrom P-450.
English: After the 2 mg/kg weekly subcutaneous administration in Cohort 2 the mean (SD) AUCτ was 138595 (6958) and 136109 (41875) following the first and the third dose, respectively.
Maltese: Wara l-għoti taħt il-ġilda ta' 2 mg/kg kull ġimgħa f'Koort 2, il-medja (SD) tal-AUCτ kienet ta' 138595 (6958) u 136109 (41875) wara l-ewwel u t-tielet doża, rispettivament.
English: The active substance in Strensiq can replace the missing enzyme (alkaline phosphatase) in hypophosphatasia.
Maltese: Is-sustanza attiva fi Strensiq tista' tissostitwixxi l-enzima nieqsa (alkaline phosphatase) f'ipofosfatasija.
English: Alkaline Phosphatase (ALP) is used as the detection reagent in many routine laboratory assays.
Maltese: Alkaline Phosphatase (ALP) jintuża bħala r-reaġent għall-osservazzjoni f'ħafna assaġġi ta' rutina tallaboratorju.
English: Nephrolithiasis
Maltese: Nefrolitijasi
English: The average ± SD elimination half-life following subcutaneous administration was 2.28 ± 0.58 days.
Maltese: Il-medja tal-half-life tal-eliminazzjoni ±SD wara l-għoti taħt il-ġilda kienet ta' 2.28 ± 0.58 jiem.
English: Disproportionate weight gain Patients may display disproportionate weight increase.
Maltese: Żieda sproporzjonata fil-piż Il-pazjenti jistgħu juru żieda sproporzjonata fil-piż.
English: Pharmacokinetics of asfotase alfa were evaluated in a 1-month, multicenter, open-label, dose-escalating, study in adults with hypophosphatasia.
Maltese: Il-farmakokinetika ta' asfotase alfa ġiet evalwata fi studju li dam xahar, multiċentriku, open-label, b'doża dejjem tiżdied f'adulti b'ipofosfatasija.
English: Study ENB-006-09/ENB-008-10 was an open-label, randomised study.
Maltese: L-istudju ENB-006-09/ENB-008-10 kien open-label, u studju li fih il-parteċipanti ntgħażlu b'mod każwali.
English: Choose an injection site (thighs, abdomen, arms (deltoids), buttocks).
Maltese: Agħżel post fejn tagħti l-injezzjoni (koxox, żaqq, dirgħajn (deltoids), warrani).
English: • Information on reporting side effect
Maltese: • Informazzjoni dwar kif għadhom jiġu rrappurtati l-effetti sekondarji
English: Age at inclusion was from 13 to 66 years and was between 17 and 72 years at study completion.
Maltese: L-età fl-inklużjoni kienet minn 13 sa 66 sena u kienet bejn 17 u 72-il sena fit-tmiem tal-istudju.
English: Each vial contains 0.3 ml solution and 12 mg of asfotase alfa (40 mg/ml).
Maltese: Kull kunjett fih 0.3 ml ta' soluzzjoni u 12 mg ta' asfotase alfa (40 mg/ml).
English: Hypoaesthesia oral Nausea
Maltese: Ipoestesija orali
English: Nineteen patients were enrolled, 14 completed, and 5 discontinued.
Maltese: Dsatax-il pazjent ġew irreġistrati, 14 komplew l-istudju, u 5 ma komplewx l-istudju.
English: Table 1 gives the adverse reactions observed from clinical trials.
Maltese: Tabella 1 turi r-reazzjonijiet avversi osservati mill-provi kliniċi li saru.
English: Asfotase alfa is a human recombinant tissue-nonspecific alkaline phosphatase-Fc-deca-aspartate fusion protein that is expressed in an engineered Chinese hamster ovary cell line.
Maltese: Asfotase alfa hu proteina tal-fużjoni alkaline phosphatase-Fc-deca-aspartate mhux speċifika għat-tessut rikombinanti uman li hi espressa f'razza ta' ċelluli tal-ovarji tal-ħamster Ċiniż prodotti mill-inġinerija.
English: For 10 patients in the per-protocol set (excludes those patients who received oral vitamin D between baseline and week 24) who underwent biopsy of the trans-iliac bone crest before and after receiving asfotase alfa:
Maltese: Għal 10 pazjenti fis-sett skont il-protokoll (li jeskludi dawk il-pazjenti li rċivew vitamina D orali bejn il-linja bażi u ġimgħa 24) li tteħditilhom bijopsija tat-trans-iliac bone crest qabel u wara li rċivew asfotase alfa:
English: The pharmacokinetic variables characterized by population pharmacokinetic analysis represent the overall hypophosphatasia patient population with age range from 1 day to 66 years, subcutaneous doses of up to 28 mg/kg/week and a range of disease onset cohorts.
Maltese: Il-varjabbli farmakokinetiċi kkaratterizzati minn analiżi farmakokinetika talpopolazzjoni jirrappreżentaw il-popolazzjoni globali ta' pazjenti b'ipofosfatasija, b'medda ta' età minn jum wieħed sa 66 sena, dożi taħt il-ġilda ta' sa 28 mg/kg/ġimgħa u medda ta' koorti bil-bidu tal-marda.
English: • This total dose can be given either as an injection of 1 mg/kg asfotase alfa 6 times per week or as 2 mg/kg asfotase alfa 3 times per week depending on the recommendation of your doctor.
Maltese: • Din id-doża totali tista' tingħata jew bħala injezzjoni ta' 1 mg/kg ta' asfotase alfa 6 darbiet filġimgħa jew bħala 2 mg/kg ta' asfotase alfa 3 darbiet fil-ġimgħa, skont ir-rakkomandazzjoni tattabib tiegħek.
English: Each vial contains 0.45 ml solution and 18 mg of asfotase alfa (40 mg/ml).
Maltese: Kull kunjett fih 0.45 ml ta' soluzzjoni u 18 mg ta' asfotase alfa (40 mg/ml).
English: Most injection site reactions were mild and selflimiting, and the majority (> 99%) were reported as non-serious.
Maltese: Il-biċċa l-kbira tar-reazzjonijiet fissit tal-injezzjoni kienu ħfief u jillimitaw lilhom infushom, u l-maġġoranza (> 99%) kienu rrappurtati bħala mhux serji.
English: Very common: may affect more than 1 in 10 people Reactions at the injection site during the injection of the medicine or during the hours following the injection (which can lead to redness, discolorations, itching, pain, fatty lumps or decreased fatty tissue on the surface of the skin, skin hypopigmentation, and/or swelling) Fever (pyrexia), irritability
Maltese: Komuni ħafna: jistgħu jaffettwaw aktar minn 1 minn kull 10 persuni Reazzjonijiet fis-sit tal-injezzjoni waqt l-injezzjoni tal-mediċina jew matul is-sigħat wara l-injezzjoni (li jistgħu jwasslu għal ħmura, tibdil fil-kulur, ħakk, uġigħ, għoqod tax-xaħam jew tnaqqis tat-tessut xaħmi fil-wiċċ tal-ġilda, ipopigmentazzjoni tal-ġilda, u/jew nefħa) Deni (piressija), irritabilità
English: Among 109 hypophosphatasia patients enrolled in the clinical studies and who have post baseline antibody data available, 97/109 (89.0%) tested positive for anti-drug antibodies at some time point after starting Strensiq treatment.
Maltese: Fost 109 pazjent b'ipofosfatasija rreġistrati fl-istudji kliniċi, u li kellhom data ta'wara l-linja bażi dwar l-antikorpi disponibbli, 97/109 (89.0%) instabu li kienu pożittivi għall-antikorpi ta' kontra l-mediċina f'xi punt ta' żmien wara li bdew il-trattament bi Strensiq.
English: • Instructions on the correct dose to be administered
Maltese: • Istruzzjonijiet dwar id-doża korretta li trid tingħata
English: Each vial contains 0.7 ml solution and 28 mg of asfotase alfa (40 mg/ml).
Maltese: Kull kunjett fih 0.7 ml ta' soluzzjoni u 28 mg ta' asfotase alfa (40 mg/ml).
English: Each vial contains 80 mg of asfotase alfa (80 mg/0.8 ml)
Maltese: Kull kunjett fih 80 mg ta' asfotase alfa (80 mg/0.8 ml).
English: The central and peripheral clearance estimates for a patient with body weight of 70 kg (and 95% CI) were 15.8 (13.2, 18.9) L/day and 51.9 (44.0, 61.2) L/day, respectively.
Maltese: 8 (13.2, 18.9) L/jum u 51.9 (44.0, 61.2) L/jum, rispettivament.
English: Prior to launch of Strensiq in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Maltese: (MAH) irid jaqbel dwar il-kontenut u l-format tal-programm edukattiv, li jinkludi media talkomunikazzjoni, modalitajiet ta' distribuzzjoni, u kwalunkwe aspetti oħra tal-programm, mal-Awtorità Kompetenti Nazzjonali.
English: Lipodystrophy
Maltese: Ċikatriċi
English: What Strensiq looks like and contents of the pack Strensiq is presented as a clear colourless to slightly yellow aqueous solution for injection in vials containing 0.3 ml, 0.45 ml, 0.7 ml and 1 ml of solution.
Maltese: Strensiq hu ppreżentat bħala soluzzjoni għall-injezzjoni akwea, ċara, bla kulur sa ftit safra, f'kunjetti li jkun fihom 0.3 ml, 0.45 ml, 0.7 ml u 1 ml ta' soluzzjoni.
English: Cohort 2 (n=3) received asfotase alfa 3 mg/kg intravenously the first week followed by 3 doses at 2 mg/kg subcutaneous at weekly intervals from weeks 2 to 4.
Maltese: Koort 2 (n = 3) irċieva asfotase alfa 3 mg/kg ġol-vini fl-ewwel ġimgħa segwit minn 3 dożi ta' 2 mg/kg taħt il-ġilda f'intervalli ta' kull ġimgħa minn ġimgħat 2 sa 4.
English: Study ENB-002-08/ENB-003-08 was an open-label, non-randomised, non-controlled study.
Maltese: L-istudju ENB-002-08/ENB-003-08 kien open-label, u studju li fih il-parteċipanti ma ntgħażlux b'mod każwali, u ma kienx ikkontrollat.
English: Each vial contains 0.8 ml solution and 80 mg of asfotase alfa (100 mg/ml).
Maltese: Kull kunjett fih 0.8 ml ta' soluzzjoni u 80 mg ta' asfotase alfa (100 mg/ml).
English: In asfotase alfa clinical studies adverse events of craniosynostosis (associated with increased intracranial pressure), including worsening of pre-existing craniosynostosis and occurrence of Arnold-Chiari malformation, have been reported in hypophosphatasia patients < 5 years of age.
Maltese: Fi studji kliniċi dwar asfotase alfa, ġew irrappurtati avvenimenti avversi ta' kranjosinostożi (assoċjati ma' żieda fil-pressjoni intrakranjali), li jinkludu l-aggravament ta' krajnosinostożi li kienet teżisti minn qabel u l-okkorrenza ta' malformazzjoni Arnold-Chiari f'pazjenti b'ipofosfatasija li kellhom < 5 snin.
English: • In studies, some eye-related side-effects have been reported both in patients using Strensiq and those who were not, probably associated with hypophosphatasia.
Maltese: • Fl-istudji, xi effetti sekondarji relatati mal-għajnejn ġew irrappurtati kemm f'pazjenti li kienu qed jużaw Strensiq u dawk li ma kinux, probabbilment assoċjati ma' ipofosfatasija.
English: Adult patients Efficacy and safety data in patients with hypophosphatasia >18 years old are limited.
Maltese: Data dwar l-effikaċja u s-sigurtà f'pazjenti b'ipofosfatasija li jkollhom >18-il sena hi limitata.
English: A total of 24/69 (35%) patients displayed apparent catch-up height-gain and 32/69 (46%) patients displayed apparent catch-up weight-gain, as shown by movement over time to a higher percentile on CDC growth charts.
Maltese: Total ta' 24/69 (35%) ta' pazjenti wrew żieda fit-tul ta' catch-up apparenti u 32/69 (46%) ta' pazjenti wrew żieda fil-piż ta' catch-up apparenti, kif muri mill-moviment maż-żmien għal perċentil ogħla fuq iċ-ċarts tat-tkabbir ta' CDC. 40/69 ta' pazjenti u 32/69 ta' pazjenti ma wrewx żieda fit-tul u fil-piż ta' catch-up apparenti, rispettivament. 4 pazjenti ma kellhomx biżżejjed dejta biex ikun jista' jsir ġudizzju u pazjent wieħed ma setax jiġi ddeterminat b'ċertezza.
English: Tetracycline for bone-labelling was administered in two 3-day courses (separated by a 14-day interval) prior to acquisition of the bone biopsy.
Maltese: Tetracycline għat-tikkettar tal-għadam ingħata f'żewġ korsijiet ta' 3 ijiem (separati b'intervall ta' 14il jum) qabel l-akkwist tal-bijopsija tal-għadam.
English: Each vial contains 1.0 ml solution and 40 mg of asfotase alfa (40 mg/ml).
Maltese: Kull kunjett fih 1.0 ml ta' soluzzjoni u 40 mg ta' asfotase alfa (40 mg/ml).
English: The study employed historical controls from the same centres as patients who received asfotase alfa and who had been subject to a similar protocol of clinical management.
Maltese: L-istudju utilizza kontrolli storiċi mill-istess ċentri bħal dak tal-pazjenti li rċivew asfotase alfa u li kienu suġġetti għal protokoll simili ta' mmaniġġjar kliniku.
English: Administration of asfotase alfa will interfere with routine measurement of serum alkaline phosphatase by hospital laboratories resulting in serum alkaline phosphatase activity measurements of several thousand units per litre.
Maltese: L-għoti ta' asfotase alfa se jinterferixxi mal-kejl ta' rutina ta' alkaline phosphatase fis-serum mill-laboratorji tal-isptar, u dan jirriżulta f'kejl ta' attività ta' alkaline phosphatase fis-serum ta' diversi eluf ta' unitajiet kull litru.
English: • Should you experience anaphylactic reaction, or an event with similar symptoms, your doctor will discuss with you the next steps and the possibility to restart Strensiq under medical supervision.
Maltese: • Jekk ikollok reazzjoni anafilattika, jew episodju b'sintomi simili, it-tabib tiegħek se jiddiskuti miegħek l-passi li jmiss u l-possibbiltà li tibda Strensiq mill-ġdid taħt superviżjoni medika.
English: NAME OF THE MEDICINAL PRODUCT Strensiq 100 mg/ml solution for injection asfotase alfa
Maltese: Strensiq 100 mg/ml injezzjoni asfotase alfa
English: In asfotase alfa clinical studies ophthalmic (conjunctival and corneal) calcification and nephrocalcinosis have been reported in patients with hypophosphatasia.
Maltese: Fi studji kliniċi dwar asfotase alfa kalċifikazzjoni oftalmika (tal-konġuntiva u tal-kornea) u nefrokalċinożi, ġew irrappurtati f'pazjenti b'ipofosfatasija.
English: Study ENB-009-10 was an open-label, randomised study.
Maltese: L-istudju ENB-009-10 kien open-label, u studju li fih il-parteċipanti jintgħażlu b'mod każwali.
English: Do not freeze.
Maltese: Aħżen fi friġġ.
English: Hypophosphatasia is a rare, severe, and potentially fatal, genetic disorder caused by loss-of-function mutation(s) in the gene encoding tissue non-specific alkaline phosphatase.
Maltese: L-ipofosfatasija hi disturb ġenetiku rari, sever, u potenzjalment fatali, ikkawżat minn mutazzjoni(jiet) ta' telf ta' funzjoni f'alkaline phosphatase mhux speċifiku għat-tessut li jikkodifika l-ġeni.
English: • Detailed description on how Strensiq is injected using aseptic techniques
Maltese: • Deskrizzjoni dettaljata dwar kif Strensiq jiġi injettat bl-użu ta' tekniki asettiċi
English: Common: may affect up to 1 in 10 people Chills
Maltese: Komuni: jistgħu jaffettwaw sa 1 minn kull 10 persuni Tertir ta' bard
English: Each vial of 1 ml solution (40 mg/ml) contains 40 mg of asfotase alfa.
Maltese: Kull kunjett ta' 1 ml ta' soluzzjoni (40 mg/ml) fih 40 mg ta' asfotase alfa.
English: The onset of hypophosphatasia was under 6 months in 4 patients, between 6 months and 17 years in 14 patients, and over 18 years in one patient.
Maltese: Il-bidu tal-ipofosfatasija kien taħt 6 xhur f'4 pazjenti, bejn 6 xhur u 17-il sena f'14-il pazjent, u aktar minn 18-il sena f'pazjent wieħed.
English: A few case reports of anaphylactoid/hypersensitivity reaction have been received in the clinical trial setting.
Maltese: Xi ftit rapporti ta' każijiet ta' reazzjoni anafilattojde/ta' sensittività eċċessiva ġew riċevuti fil-kuntest tal-prova klinika.
English: Strensiq 40 mg/ml solution for injection EU/1/15/1015/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Strensiq 40 mg/ml soluzzjoni għall-injezzjoni EU/1/15/1015/001
English: Supplements of calcium and oral vitamin D may be required.
Maltese: Supplimenti ta' calcium u vitamina D orali jistgħu jkunu meħtieġa.
English: The treating physician should inform the testing lab that the patient is treated with medication affecting the ALP levels.
Maltese: It-tabib kuranti għandu jinforma lill-laboratorju tal-ittestjar li l-pazjent qed jiġi ttrattat b'mediċini li jaffettwaw il-livelli ta' ALP.
English: Strensiq is indicated for long-term enzyme replacement therapy in patients with paediatric-onset hypophosphatasia to treat the bone manifestations of the disease (see section 5.1).
Maltese: Strensiq hu indikat għal terapija fit-tul tas-sostituzzjoni tal-enzimi f'pazjenti b'ipofosfatasija li bdiet fi żmien it-tfulija, għat-trattament ta' manifestazzjonijiet tal-għadam tal-marda (ara sezzjoni 5.1).
English: Skin redness (erythema)
Maltese: Deni (piressija), irritabilità
English: The other ingredients are sodium chloride, sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate and water for injections.
Maltese: Is-sustanzi mhux attivi l-oħra huma sodium chloride, sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate u ilma għall-injezzjonijiet.
English: Ophthalmology examination and renal ultrasounds are recommended at baseline and periodically in hypophosphatasia patients.
Maltese: Eżami oftalmoloġiku u ultrasounds tal-kliewi huma rakkomandati fil-linja bażi u perjodikament f'pazjenti b'ipofosfatasija.
English: * produced by recombinant DNA technology using mammalian Chinese Hamster Ovary (CHO) cell culture.
Maltese: * magħmul minn teknoloġija ta' DNA rikombinanti bl-użu ta' koltura ta' ċelluli tal-mammiferi tal-Ovarju tal-Ħamster Ċiniż (CHO).
English: Injection site reactions1 Pyrexia
Maltese: Tabella 1: Reazzjonijiet Avversi
English: Following repeated subcutaneous administration to pregnant mice in the therapeutic dose range (>0.5 mg/kg), asfotase alfa levels were quantifiable in fetuses at all doses tested, suggesting cross-placental transport of asfotase alfa.
Maltese: Wara għoti ripetut taħt il-ġilda lil ġrieden tqal fil-medda tad-doża terapewtika (>0.5 mg/kg), il-livelli ta' asfotase alfa kienu kwantifikabbli fil-feti fid-dożi kollha ttestjati, li jissuġġerixxi trasport minn ġolplaċenta ta' asfotase alfa.
English: • Increase of parathyroid hormone concentration and low calcium levels have been reported in studies.
Maltese: • Ġiet irrappurtata żieda fil-konċentrazzjoni tal-ormon paratirojde u livelli baxxi ta' calcium fl-istudji.