FrancophonIA/ELRC3.0 huggingface dataset:
English: Epidemiological studies in women who use low dose combined oral contraceptives (<50 μg ethinylestradiol) have found that out of 10,000 women between about 6 and 12 will develop a VTE in one year.
Maltese: Studji epidemjoloġiċi f'nisa li jużaw kontraċettivi orali kombinati ta' doża baxxa (<50 μg ethinylestradiol) sabu li minn 10,000 mara, bejn madwar 6 u 12 jiżviluppaw VTE f'sena.
English: ANNEX III.C - dienogest containing combined hormonal contraceptives
Maltese: ANNESS III.C - kontraċettivi ormonali kombinati li fihom dienogest
English: It is estimated1 that out of 10,000 women who use a CHC containing drospirenone, between 9 and 12 women will develop a VTE in one year; this compares with about 62 in women who use a levonorgestrel-containing CHC.
Maltese: Hu stmat1 li minn 10,000 mara li jużaw CHC li fih drospirenone, bejn 9 u 12-il mara jiżviluppaw VTE f'sena; dan jipparaguna ma' madwar 62 f'nisa li jużaw CHC li jkun fih levonorgestrel.
English: • if you have a problem with your heart (valve disorder, disturbance of the rhythm called atrial fibrillation)
Maltese: • jekk għandek xi problema f'qalbek (disturb fil-valvs, disturb fir-ritmu ta' taħbit tal-qalb li jissejjaħ fibrillazzjoni atrijali);
English: Epidemiological studies in women who use low dose (<50 μg ethinylestradiol) combined hormonal contraceptives have found that out of 10,000 women between about 6 and 12 will develop a VTE in one year
Maltese: Studji epidemjoloġiċi f'nisa li jużaw kontraċettivi ormonali kombinati ta' doża baxxa (<50 μg ethinylestradiol) sabu li minn 10,000 mara, bejn madwar 6 u 12 jiżviluppaw VTE f'sena.
English: • If you have an inflammation in the veins under the skin (superficial thrombophlebitis);
Maltese: • Jekk għandek infjammazzjoni fil-vini taħt il-ġilda (tromboflebite superfiċjali);
English: Seek urgent medical attention - if you notice possible signs of a blood clot that may mean you are suffering from a blood clot in the leg (i.e. deep vein thrombosis), a blood clot in the lung (i.e. pulmonary embolism), a heart attack or a stroke (see ‘Blood clot' (thrombosis) section below.
Maltese: Fittex għajnuna medika urġenti - jekk tinnota sinjali possibbli ta' embolu tad-demm li jista' jfisser li inti qed tbati minn embolu tad-demm fir-riġel (i.e. trombożi fil-vini tal-fond), embolu fil-pulmun (i.e. emboliżmu pulmonari), attakk tal-qalb jew puplesija (ara s-sezzjoni ‘Embolu taddemm (trombożi)' hawn taħt.
English: • Very rarely a clot may form in a vein in another organ such as the eye (retinal vein thrombosis).
Maltese: • B'mod rari ħafna, embolu jista' jifforma f'vina f'organu ieħor bħall-għajn (trombożi fil-vini tar retina).
English: - a condition known as hyperhomocysteinaemia • if you have (or have ever had) a type of migraine called ‘migraine with aura';
Maltese: • jekk għandek (jew qatt kellek) tip ta' emigranja msejħa ‘emigranja b'awra';
English: It is estimated1 that out of 10,000 women who use a CHC containing gestodene between 9 and 12 women will develop a VTE in one year; this compares with about 62 in women who use a levonorgestrel-containing CHC.
Maltese: Hu stmat1 li minn 10,000 mara li jużaw CHC li fih gestodene bejn 9 u 12-il mara jiżviluppaw VTE f'sena; dan jipparaguna ma' madwar 62 f'nisa li jużaw CHC li jkun fih levonorgestrel.
English: You can also report side effects directly via the national reporting system listed in Appendix V*.
Maltese: Tista' wkoll tirrapporta effetti sekondarji permezz tas-sistema ta' rappurtar nazzjonali imniżżla f'Appendiċi V*.
English: Out of 10,000 women who use a levonorgestrel-containing CHC about 61 will develop a VTE in one year.
Maltese: Minn 10,000 mara li jużaw CHC li fih levonorgestrel, madwar 61 jiżviluppaw VTE f'sena.
English: • if you have haemolytic uraemic syndrome (HUS - a disorder of blood clotting causing failure of the kidneys);
Maltese: • jekk għandek sindrome uremiku emolitiku (HUS [haemolytic uraemic syndrome] - disturb fit tagħqid tad-demm li jikkawża insuffiċjenza tal-kliewi);
English: Retinal vein thrombosis (blood clot in the eye)
Maltese: Sintomi ta' trombożi fil-vini tal-fond (DVT - deep vein thrombosis) jistgħu jinkludu:
English: Epidemiological studies have associated the use of CHCs with an increased risk for arterial thromboembolism (myocardial infarction) or for cerebrovascular accident (e.g. transient ischaemic attack, stroke).
Maltese: Studji epidemjoloġiċi assoċjaw l-użu ta' CHCs ma' żieda fir-riskju ta' tromboemboliżmu fl-arterji (infart mijokardijaku) jew ta' inċident ċerebrovaskulari (eż. attakk iskemiku temporanju, puplesija).
English: BLOOD CLOTS IN AN ARTERY
Maltese: F'ARTERJA
English: • sweating, nausea, vomiting or dizziness;
Maltese: • għaraq, dardir, rimettar jew sturdament;
English: Deep vein thrombosis
Maltese: Trombożi fil-vini tal-fond
English: - Out of 10,000 women who are using a combined hormonal contraceptive that contains etonogestrel or norelgestromin such as [invented name] between about 6 and 12 women will develop a blood clot in a year.
Maltese: - Minn 10,000 mara li jkunu qed jużaw kontraċettiv ormonali kombinat li fih etonogestrel jew norelgestromin bħal [isem ivvintat] bejn madwar 6 u 12-il mara se jiżviluppaw embolu taddemm f'sena.
English: An increased risk of blood clots in your veins (venous thromboembolism (VTE)) or blood clots in your arteries (arterial thromboembolism (ATE)) is present for all women taking combined hormonal contraceptives.
Maltese: Żieda fir-riskju ta' emboli tad-demm fil-vini tiegħek (tromboemboliżmu fil-vini (VTE - venous thromboembolism)) jew emboli tad-demm fl-arterji tiegħek (tromboemboliżmu fl-arterji (ATE - arterial thromboembolism)) hi preżenti għan-nisa kollha li jkunu qed jieħdu kontraċettivi ormonali kombinati.
English: • severe light headedness or dizziness;
Maltese: • jekk qatt kellek xi attakk tal-qalb jew puplesija;
English: • If you have an inflammation in the veins under the skin (superficial thrombophlebitis).
Maltese: • Jekk għandek infjammazzjoni fil-vini taħt il-ġilda (tromboflebite superfiċjali).
English: • Please be alert and see your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood clots”)
Maltese: • Jekk jogħġbok kun allerta u ara lit-tabib tiegħek jekk taħseb li jista' jkollok sintomi ta' embolu tad-demm (ara sezzjoni 2 "Emboli tad-demm")
English: [The below wording should be added and the frequency of the adverse events should be aligned to that of the SmPC]
Maltese: [Il-kitba t'hawn taħt għandha tiġi miżjuda u l-frekwenza tal-avvenimenti avversi għandha tiġi allinjata ma' dik tal-SmPC]
English: • if you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be a first sign of a heart attack) or transient ischaemic attack (TIA - temporary stroke symptoms);
Maltese: • jekk għandek (jew qatt kellek) anġina pectoris (kondizzjoni li tikkawża wġigħ sever fis-sider u li tista' tkun l-ewwel sinjal ta' attakk tal-qalb) jew attakk iskemiku temporanju [TIA (transient ischaemic attack) - sintomi temporanji ta' puplesija]);
English: o A high risk of arterial thromboembolism due to multiple risk factors (see section 4.4) or to the presence of one serious risk factor such as:
Maltese: o Riskju għoli ta' tromboemboliżmu fl-arterji minħabba fatturi ta' riskju multipli (ara sezzjoni 4.4) jew il-preżenza ta' fattur wieħed ta' riskju serju bħal:
English: Before you start using [invented name] you should read the information on blood clots in section 2.
Maltese: Qabel tibda tuża [isem ivvintat], għandek taqra l-informazzjoni dwar emboli tad-demm f'sezzjoni 2.
English: [For all chlormadinone containing combined hormonal contraceptives listed in Annex I, the existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below]
Maltese: [Għall-kontraċettivi ormonali kombinati kollha li fihom chlormadinone elenkati f'Anness I, linformazzjoni eżistenti tal-prodott għandha tiġi emendata (inserzjoni, sostituzzjoni jew tħassir talkitba, kif xieraq) biex tirrifletti l-kitba li dwarha kien hemm qbil, kif deskritt hawn taħt]
English: Particularly above 35 years
Maltese: Speċjalmentment iktar minn 35 sena
English: Other signs of vascular occlusion can include: sudden pain, swelling and slight blue discoloration of an extremity.
Maltese: Sinjali oħra ta' okklużjoni vaskulari jistgħu jinkludu: uġigħ f'daqqa, nefħa u kulur ftit blu f'xi estremità.
English: [Invented name] is contraindicated if a woman has one serious or multiple risk factors for ATE that puts her at high risk of arterial thrombosis (see section 4.3).
Maltese: [Isem ivvintat] hu kontraindikat jekk mara jkollha fattur wieħed serju jew fatturi multipli ta' riskju għal ATE li jpoġġuha f'riskju għoli ta' trombożi fl-arterji (ara sezzjoni 4.3).
English: - Out of 10,000 women who are using a combined hormonal contraceptive that contains drospirenone, such as [invented name], between about 9 and 12 women will develop a blood clot in a year.
Maltese: - Minn 10,000 mara li jkunu qed jużaw kontraċettiv ormonali kombinat li fih [drospirenone, bħal [isem ivvintat], bejn madwar 9 u 12-il mara se jiżviluppaw embolu tad-demm f'sena.
English: It is estimated that out of 10,000 women who use a levonorgestrel-containing CHC about 61 will develop a VTE in one year.
Maltese: Hu stmat li minn 10,000 mara li jużaw CHC li fih levonorgestrel, madwar 61 jiżviluppaw VTE f'sena.
English: • rapid or irregular heartbeat
Maltese: • taħbit tal-qalb mgħaġġel jew irregolari
English: Note: temporary immobilisation including air travel >4 hours can also be a risk factor for VTE, particularly in women with other risk factors
Maltese: Nota: immobilizzazzjoni temporanja li tinkludi vvjaġġar bl-ajru ta' >4 sigħat, ukoll tista' tkun fattur ta' riskju għal VTE, speċjalment f'nisa b'fatturi ta' riskju oħrajn
English: dyslipoproteinaemia and systemic lupus erythematosus.
Maltese: Madankollu, dawn l-effetti sekondarji huma rari.
English: 2900AA Capelle aan den Ijssel
Maltese: 2900AA Capelle aan den Ijssel The Netherlands
English: de Europa, 20 B. Parque Empresarial La Moraleja Alcobendas 28108 MADRID Spain
Maltese: Avda. de Europa, 20 B. Parque Empresarial La Moraleja Alcobendas 28108 MADRID Spain
English: Finland Pfizer Oy, Tietokuja 4,
Maltese: Il-Finlandja Pfizer Oy, Tietokuja 4,
English: Pfizer Holding France, 23-25 avenue du Docteur Lannelongue, 75014 Paris
Maltese: Pfizer Holding France, 23-25 avenue du Docteur Lannelongue, 75014
English: Denmark Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Denmark
Maltese: Id-Danimarka Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Denmark
English: Sweden Pfizer AB , 191 90 Sollentuna, Sverige
Maltese: Pfizer AB , 191 90 Sollentuna, Sverige
English: Via Valbondione 113 00188 Rome Italy
Maltese: Pfizer Italia S.r.l. Via Valbondione 113 00188 Rome Italy
English: Luxembourg Pfizer SA 17, Boulevard de la Plaine B-1050 Bruxelles Belgium
Maltese: Il-Lussemburgu Pfizer SA 17, Boulevard de la Plaine B-1050 Bruxelles Belgium
English: Final height
Maltese: Tul finali
English: The application submitted by the MAH contained 4 company sponsored studies, including 2 pivotal trials, and 2 investigator initiative studies:
Maltese: L-applikazzjoni sottomessa mill-MAH kien fiha 4 studji sponsorjati mill-kumpanija, inkluż 2 provi ewlenin u 2 studji b'inizjattivi tal-investigatur:
English: Belgium PFIZER S.A. Boulevard de la Plaine, 17 1050 Brussels Belgium
Maltese: Boulevard de la Plaine, 17 1050 Brussels Belgium
English: On 30 July 2008, the MAH submitted a type II variation via the mutual recognition procedure for Genotropin and associated names (DK/H/0012/001,004-6,008-024/II/118), to request an extension of the indications.
Maltese: Fit-30 ta' Lulju 2008, il-MAH issottometta varjazzjoni ta' tip II permezz ta' proċedura ta' rikonoxximent reċiproku għal Genotropin u l-ismijiet assoċjati (DK/H/0012/001,004-6,008024/II/118), biex jitlob estensjoni tal-indikazzjonijiet.
English: GENOTROPIN (WITH
Maltese: GENOTROPIN (WITH PRESERVATIVE)
English: The study population included 13 children who had previously completed CTC-1.
Maltese: Il-popolazzjoni tal-istudju inkludiet 13-il tifel/tifla li qabel kienu temmew CTC-1.
English: The most severe forms of JIA often require aggressive therapy with disease modifying antirheumatic drugs (DMARDs), including biologicals, methotrexate, cyclosporine and glucocorticoids to control inflammation, arthritis and other clinical manifestations.
Maltese: L-aktar forom severi ta' JIA spiss ikunu jeħtieġu terapija aggressiva b'mediċini kontra rrewmatiżmu li jimmodifikaw il-marda (DMARDs - disease modifying antirheumatic drugs), inkluż bijoloġiċi, methotrexate, cyclosporine u glukokortikojdi biex jikkontrollaw l-infjammazzjoni, l-artrite u manifestazzjonijiet kliniċi oħrajn.
English: Pharmacia Laboratories Limited
Maltese: Pharmacia Laboratories Limited Ramsgate Road
English: The absence of such information makes the scarce data available of limited value.
Maltese: In-nuqqas ta' informazzjoni bħal din tagħmel id-dejta skarsa disponibbli minn valur limitat.
English: Clinical benefits
Maltese: Benefiċċji kliniċi
English: Data from the German national JIA registry indicates that, in 2007, around 20% of the 1941 subjects under the age of 18 required ongoing systemic glucocorticoid treatment.
Maltese: Id-dejta mir-reġistru tal-JIA nazzjonali Ġermaniż tindika li, fl-2007, madwar 20% mill-1941 suġġett taħt l-età ta' 18 kellhom bżonn ta' kura sistemika bi glukokortikojdi.
English: A total of only 68 subjects treated with Genotropin were included in the 6 studies submitted with the application.
Maltese: Total ta' 68 suġġett biss ikkurati bi Genotropin ġie inkluż fis-6 studji sottomessi mal-applikazzjoni.
English: The proposed dose, 0.047 mg/kg/day, was only used in one of the investigator published studies.
Maltese: Id-doża proposta, 0.047 mg/kg/kuljum, intużat biss f'wieħed mill-istudji ppubblikati millinvestigatur.
English: Ireland Pharmacia Laboratories Limited
Maltese: Ir-Renju Unit Pharmacia Laboratories Limited Ramsgate Road
English: It should be noted that baseline IGF-1 is usually low in JIA patients and may be further reduced by steroids.
Maltese: IGF-1 hija normalment baxxa f'pazjenti b'JIA u tista' titnaqqas iktar bi sterojdi.
English: • The Committee considered the referral made under article 6(12) of Commission Regulation (EC) No 1084/2003;
Maltese: • Il-Kumitat qies ir-referenza magħmula skont l-Artikolu 6(12) tar-Regolament talKummissjoni (KE) Nru 1084/2003;
English: The Bechtold study, the only one where the proposed dose (0.047 mg/kg/day) was used, did not reveal any glucose abnormalities.
Maltese: L-istudju Bechtold, l-uniku wieħed li fih intużat id-doża proposta (0.047 mg/kg/day), ma weriex xi anormalitajiet relatati malglucose.
English: The study included a total of 30 patients randomized to receive no treatment (controls) or Genotropin at the dose of 0.066 mg/mg/day.
Maltese: L-istudju inkluda total ta' 30 pazjent randomizzati sabiex ma jirċievu ebda kura (kontrolli) jew Genotropin fid-doża ta' 0.066 mg/mg/kuljum.
English: Netherlands Pfizer BV Postbus 37
Maltese: Pfizer BV
English: Juvenile idiopathic arthritis (JIA) is an inflammatory disorder, causing swelling, synovitis, pain, stiffness, and/or tenderness of one or multiple joints, and may also cause inflammation of other organs.
Maltese: Artrite idjopatika taż-żgħażagħ (JIA - Juvenile idiopathic arthritis) hija disturb infjammatorju, li jikkawża nefħa, sinovite, uġigħ, ebusija, u/jew sensittività ta' ġog wieħed jew aktar, u tista' tikkawża wkoll infjammazzjoni ta' organi oħrajn.
English: The study was conducted in 2 centers in France and included a total of 30 subjects who received Genotropin at the dose of 0.066 mg/kg/day.
Maltese: Listudju twettaq f'2 ċentri fi Franza u nkluda total ta' 30 suġġett li rċevew Genotropin fid-doża ta' 0.066 mg/kg/kuljum.
English: However, even if it is understood that the population eligible for treatment is limited, the efficacy database in absolute numbers is small.
Maltese: Madankollu, anki jekk ikun mifhum li l-popolazzjoni eleġibbli għal kura hija waħda limitata, iddatabase tal-effikaċja f'numri assoluti hija żgħira.
English: In CTC-2, all subjects received Genotropin 0.066 mg/kg/day for 36 months.
Maltese: F'CTC-2, is-suġġetti kollha rċevew Genotropin 0.066 mg/kg/kuljum għal 36 xahar.
English: • The Committee considered that there are potential long term risks associated with growth hormone treatment (such as tumour promotion or diabetes), which may be aggravated in this indication by the prolonged concomitant administration of corticosteroids;
Maltese: • Il-Kumitat qies li hemm riskji potenzjali fit-tul assoċjati mal-kura bl-ormoni tat-tkabbir (bħallpromozzjoni tat-tumuri jew dijabete), li jistgħu jiġu aggravati f'din l-indikazzjoni b'għoti flistess ħin prolongat ta' kortikosterojdi;
English: The long term safety of the combination between glucocorticoids and growth hormone was not addressed in the trials conducted.
Maltese: Is-sigurtà fit-tul tal-kombinazzjoni bejn glukokortikojdi u ormoni tat-tkabbir ma ġietx indirizzata fil-provi mwettqa.
English: Only 4 of the 6 studies were conducted by the MAH (the remaining were investigator initiated published studies), and only 1 of these 4 included a control group.
Maltese: 4 biss mis-6 studji twettqu mill-MAH (il-bqija kienu studji ppubblikati mibdija mill-investigatur), u 1 biss minn dawn l-4 inkluda grupp ta' kontroll.
English: Overall, in the studies presented, the safety profile was comparable to that of other Genotropin indications and consistent with its pharmacological class.
Maltese: B'mod ġenerali, fl-istudji ppreżentati, il-profil tas-sigurtà kien komparabbli ma' dak ta' indikazzjonijiet Genotropin oħrajn u kien konsistenti mal-klassi farmakoloġika tiegħu.
English: Whilst the acute safety was considered to raise little concern, the uncertainty regarding long-term safety was highlighted by the SAG experts.
Maltese: Filwaqt li s-sigurtà akuta kienet meqjusa li tqajjem ftit tħassib, l-inċertezza firrigward tas-sigurtà fit-tul ġiet enfasizzata mill-esperti tal-SAG.
English: Data from the MAH sponsored trials, as well as the Bechtold study, failed to prove a clinically relevant effect on final height, BMD and body composition.
Maltese: Dejta mill-provi sponsorjati tal-MAH, kif ukoll l-istudju ta' Bechtold, naqsu milli jagħtu prova taleffett rilevanti kliniku dwar it-tul finali, il-BMD u l-kompożizzjoni tal-ġisem.
English: Pivotal study CTC-4 was a phase 3, non-randomised, non-controlled, 36-month, open-label study that evaluated genotropin in prepubertal or pubertal children with short stature secondary to longterm glucocorticoid therapy for treatment of JIA or nephritic syndrome.
Maltese: Studju ewlieni CTC-4 kien studju open-label ta' 36 xahar, mhux ikkontrollat, mhux randomizzat, ta' fażi 3 li evalwa genotropin fi tfal prepubertali jew pubertali bi statura qasira sekondarja għal terapija bi glukokortikojdi fuq perjodu ta' żmien twil għall-kura ta' JIA jew sindromu nefritiku.
English: Pivotal study CTC-3 was a phase 3, open-label, randomised, controlled, 36-months prospective, single center study that evaluated early treatment with Genotropin versus untreated controls in the prevention of growth retardation of children with severe JIA requiring long-term corticosteroid therapy.
Maltese: Studju ewlieni CTC-3 kien studju prospettiv b'ċentru wieħed ta' 36 xahar, ikkontrollat, randomizzat, open-label ta' fażi 3 li evalwa trattament bikri b'Genotropin kontra kontrolli mhux ikkurati filprevenzjoni ta' dewmien fit-tkabbir ta' tfal b'JIA severa li jeħtieġu terapija ta' kortikosterojdi għal perjodu ta' żmien twil.
English: • The Committee considered that the Marketing Authorisation Holders did not present data demonstrating the efficacy of Genotropin in the proposed indication and for the proposed posology.
Maltese: • Il-Kumitat qies li d-Detenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq ma ppreżentawx dejta li turi l-effikaċja ta' Genotropin fl-indikazzjoni proposta u għall-pożoloġija proposta.
English: Supportive study CTC-1 was a non-randomised, non-controlled, open-label, single center pilot study that evaluated Genotropin in prepubertal children with short stature secondary to long-term glucocorticoid therapy for treatment of JIA.
Maltese: Studju ta' appoġġ CTC-1 kien studju pilota b'ċentru wieħed, open-label, mhux ikkontrollat, mhux randomizzat li evalwa Genotropin fi tfal prepubertali bi statura qasira sekondarja għal terapija bi glukokortikojdi fit-tul għall-kura ta' JIA.
English: Two investigator-initiated studies (Bechtold and Grote) were also included in the application.
Maltese: Żewġ studji mibdija minn investigatur (Bechtold u Grote) ġew inklużi wkoll fl-applikazzjoni.
English: In about 20% of the optimal treated patients, glucocorticoid treatment is necessary.
Maltese: F'madwar 20% tal-pazjenti kkurati b'mod ottimali, ikun hemm bżonn ta' kura bi glukokortikojdi.
English: The study designs and efficacy endpoints were similar as those of the pivotal/supportive studies, except that smaller doses were used (0.0290.047 mg/kg/day in Bechtold and 0.045 mg/kg/day in Grote).
Maltese: 047 mg/kg/kuljum f'Bechtold u 0.045 mg/kg/kuljum fi Grote).
English: A total of 15 patients received Genotropin for 12 months at the dose of 0.066 mg/kg/day followed by 12 months without Genotropin treatment.
Maltese: Total ta' 15-il pazjent irċevew Genotropin għal 12-il xahar fid-doża ta' 0.066 mg/kg/kuljum segwiti minn 12-il xahar mingħajr kura b'Genotropin.
English: In the pivotal trials conducted by the MAH, a dose higher than the dose proposed was used and, as very limited final height data is available, the clinical relevance of the effect was not demonstrated.
Maltese: Fil-provi ewlenin mwettqa mill-MAH, intużat doża ogħla minn dik proposta u, minħabba li ftit li xejn hemm dejta dwar it-tul finali, ir-rilevanza klinika tal-effett ma ntwerietx.
English: Supportive study CTC-2 was a non-randomised, non-controlled, open-label, single center study that evaluated Genotropin in children with JIA and short stature secondary to glucocorticoid therapy.
Maltese: Studju ta' appoġġ CTC-2 kien studju b'ċentru wieħed, open-label, mhux ikkontrollat, mhux randomizzat li evalwa Genotropin fi tfal b'JIA u bi statura qasira sekondarja għal terapija bi glukokortikojdi.
English: Regarding safety, concerns exist on the potential long term risks associated with growth hormone treatment (such as tumour promotion or diabetes), which may be aggravated in this indication by the prolonged concomitant administration of corticosteroids.
Maltese: Fir-rigward tas-sigurtà, jeżisti tħassib dwar ir-riskji potenzjali fit-tul b'kura b'ormoni tat-tkabbir (bħall-promozzjoni ta' tumuri jew dijabete), li jistgħu jiġu aggravati f'din l-indikazzjoni mill-għoti flistess ħin u prolongat tal-kortikosterojdi.
English: Improvement in body composition and Bone Mineral Density (BMD) In the studies conducted by the MAH, no clear and significant effect of Genotropin therapy was demonstrated on improvement of body composition or BMD.
Maltese: Titjib fil-kompożizzjoni tal-ġisem u fid-Densità tal-Minerali tal-Għadam (BMD) Fl-istudji mwettqa mill-MAH, ma ntwera ebda effett ċar u sinifikanti b'terapija ta' Genotropin fuq ittitjib tal-kompożizzjoni tal-ġisem jew BMD.
English: The pivotal trials supporting the application did not include information on quality of life, in addition to the lack of information on final height.
Maltese: Il-provi ewlenin li jappoġġjaw l-applikazzjoni ma nkludewx informazzjoni dwar ilkwalità tal-ħajja, apparti n-nuqqas ta' informazzjoni dwar it-tul finali.
English: The diagnosis of growth disturbance should be confirmed by a current height SDS <-2 or a growth velocity SDS < -1, measured over a period of at least 12 months.
Maltese: SDS <-2 jew veloċità tat-tkabbir SDS < -1, imkejla fuq perjodu ta' mill-inqas 12-il xahar.