FrancophonIA/ELRC3.0 huggingface dataset:
English: Rare: Transient thrombocytopenia.
Maltese: Prodott mediċinali li jingħata bir-riċetta tat-tabib.
English: NAME OF THE MEDICINAL PRODUCT Focetria suspension for injection in multidose container Influenza vaccine H1N1v (surface antigen, inactivated, adjuvanted)
Maltese: Focetria suspensjoni għall-injezzjoni f'kontenitur b'ħafna dożi Vaċċin kontra l-influwenza H1N1v (antiġeni tal-wiċċ, inattivati, adjuvantat)
English: Data on responses to a second dose administered after an interval of three weeks showed an increase in overall GMT from 274 to 1700 (N=57) and an increase in GMT from 162 to 1399 in children who were seronegative at baseline (N=37).
Maltese: Tagħrif fuq risponsi għal tieni doża mogħtija wara intervall ta' tliet ġimgħat wera żieda fil-GMT ġenerali minn 274 għal 1700 (N=57) u żieda fl-GMT minn 162 għal 1399 fi tfal li kienu seronegattivi fil-linja bażi (N=37).
English: History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (egg and chicken proteins, ovalbumin, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB)) of this vaccine.
Maltese: Storja ta' reazzjoni anafilattika (jiġifieri ta' periklu għall-ħajja) għal xi wieħed mill-kostitwenti jew traċċi residwi (bajd u proteini tat-tiġieġ, ovalbumin, kanamycin u neomycin sulphate, formaldehyde u cetyltrimethylammonium bromide (CTAB)) ta' dan il-vaċċin.
English: This vaccine in a multi-dose vial contains thiomersal as a preservative and it is possible that you may experience an allergic reaction.
Maltese: Dan il-vaċċin f'kunjett ta' diversi dożi fih thiomersal bħala preservattiv u jista' jkun possibbli li jkollok xi reazzjoni allerġika.
English: Sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, sodium citrate, citric acid, thiomersal, water for injections.
Maltese: Sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, sodium citrate, citric acid, thiomersal, ilma għall-injezzjoni.
English: • if you have a severe infection with a high temperature (over 38°C).
Maltese: • jekk għandek infezzjoni severa b'temperatura għolja (aktar minn 38oC).
English: Neurological disorders such as severe stabbing or throbbing pain along one or more nerves, tingling, fits, and neuritis (inflammation of nerves).
Maltese: Disturbi newroloġiċi bħal uġigħ qawwi simili għal daqqiet ta' sikkina jew titqib tul nervitura waħda jew aktar, tnemnim, aċċessjonijiet u newrite (infjammazzjoni tan-nervituri).
English: Influenza vaccine H1N1v
Maltese: Vaċċin kontra l-influwenza H1N1v
English: Sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, sodium citrate, citric acid, water for injections.
Maltese: Sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, sodium citrate, citric acid, ilma għall-injezzjoni.
English: Focetria H1N1v may be co-administered with a non adjuvanted seasonal influenza vaccine.
Maltese: H1N1v tista' tingħata flimkien ma' vaċċin kontra l-influwenza staġjonali mhux adjuvantat.
English: General side effects reported very commonly in the 6 months-35 months of age group per dose were irritability, unusual crying, sleepiness, diarrhoea and change in eating habits.
Maltese: Effetti sekondarji rrapportati b'mod komuni ħafna fil-grupp ta' etajiet ta' bejn is-6 xhur u l-35 xahar kienu irritabilità, biki mhux tas-soltu, ngħas, dijarea u bidla fid-drawwiet tal-ikel.
English: Vial containing ten doses (0.5 ml each) for injection:
Maltese: Kunjett li fih 10 dożi (kull wieħed 0.5 ml) għall-injezzjoni:
English: • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER Medicinal product subject to medical prescription.
Maltese: • KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIR-RIGWARD TAL-UŻU SIGUR U EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: Cough.
Maltese: Loc.
English: There are no data with Focetria using the subcutaneous route.
Maltese: Ma hemm ebda dejta b'Focetria bl-użu tar-rotta minn ġol-ġilda.
English: Very common reactions reported in children and adolescents 3 to 17 years of age: Pain, induration and erythema, malaise, myalgia, headache and fatigue.
Maltese: Reazzjonijiet komuni ħafna rrapportati fi tfal u adoloxxenti ta' bejn it-3 snin u s-17-il sena: Uġigħ, twebbis u eritema, ħass ħażin, mijalġija, uġigħ ta' ras u għejja.
English: It is recommended that subjects who receive a first dose of Focetria, should complete the vaccination course with Focetria H1N1v (see section 4.4).
Maltese: Hu rakkomandat li individwi li jirċievu l-ewwel doża ta' Focetria, għandhom ilestu l-kors ta' vaċċinazzjoni b'Focetria H1N1v (ara sezzjoni 4.4).
English: Safety data are available in pregnant women exposed to Focetria in particular during second and third trimesters.
Maltese: Dejta tas-sigurtà hi disponibbli f'nisa tqal esposti għal Focetria b'mod partikulari matul it-tieni u ttielet trimestri.
English: Clinical studies in which a version of Focetria containing HA derived from A/Vietnam/1194/2004 (H5N1) was administered at day 1 and at day 22 provide:
Maltese: Studji kliniċi li fihom, verżjoni ta' Focetria li fiha HA derivat minn A/Vietnam/1194/2004
English: The seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody to H1N1v in children aged 12-35 months by HI assay after administration of 7.5 µg of Focetria were as follows:
Maltese: Ir-rata ta' seroprotezzjoni*, rata ta' serokonverżjoni* u l-fattur ta' serokonverżjoni** għal antikorp anti HA għal H1N1v fi tfal u adoloxxenti ta' bejn 12-35 xahar b'assaġġ HI wara l-għoti ta' 7.5 µg ta' Focetria kienu kif ġej:
English: Caution is needed when administrating this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance, to any of the excipients, to thiomersal and to residues (eggs and chicken protein, ovalbumin, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB)).
Maltese: Hija meħtieġa attenzjoni meta dan il-vaċċin jingħata lil persuni b'sensittività eċċessiva magħrufa (apparti r-reazzjoni anafilattika) għas-sustanza attiva, għal xi sustanza mhux attiva, għal thiomersal u għal residwi (bajd u l-proteini tat-tiġieġ, ovalbumin, kanamycin u neomycin sulphate, formaldehyde u cetyltrimethylammonium bromide (CTAB)).
English: METHOD OF ADMINISTRATION Gently shake before use.
Maltese: METODU TA' KIF GĦANDU JINGĦATA Ħawwad qabel tuża.
English: The seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody to H1N1v in children and adolescents aged 9-17 years by HI assay administration of 7.5 µg of Focetria were as follows:
Maltese: Ir-rata ta' seroprotezzjoni*, rata ta' serokonverżjoni* u l-fattur ta' serokonverżjoni** għal antikorp anti HA għal H1N1v fi tfal u adoloxxenti ta' bejn id-9 snin u s-17-il sena b'assaġġ HI wara għoti ta' 7.5 µg ta' Focetria kienu kif ġej:
English: Postmarketing spontaneously reported adverse events, an interventional study and large observational studies do not suggest direct or indirect harmful effects of Focetria exposure on pregnancy.
Maltese: Avvenimenti avversi rrappurtati b'mod spontanju wara t-tqegħid fis-suq, studju ta' intervent u studji kbar ta' osservazzjoni, ma jissuġġerixxux effetti ħżiena diretti jew indiretti talesponiment ta' Focetria fuq it-tqala.
English: Neurological disorders, such as neuralgia, paraesthesia, convulsions and neuritis.
Maltese: Disturbi newroloġiċi, bħal newralġija, paresteżija, konvulżjonijiet u newrite.
English: Skin and subcutaneous tissue disorders Generalised skin reactions including pruritus, urticaria or non-specific rash; angioedema.
Maltese: Reazzjonijiet ġeneralizzati tal-ġilda inkluż prurite, urtikarja jew raxx mhux speċifiku; anġjoedema.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARDBOARD BOX FOR SYRINGE
Maltese: U RAĠUNIJIET BIEX TIĠI RAKKOMANDATA VARJAZZJONI FIT-TERMINI
English: The seroprotection rate*, seroconversion rate* and the seroconversion factor ** for anti-HA antibody to A/H1N1v in adult and elderly subjects by HI assay after administration of 7.5 µg of Focetria were as follows:
Maltese: Ir-rata ta' seroprotezzjoni*, ir-rata ta' serokonverżjoni* u l-fattur ta' serokonverżjoni** għall-antikorp anti-HA għal A/H1N1v f'suġġetti adulti u anzjani b'assaġġ ta' HI wara għoti ta' 7.5 µg ta' Focetria kienu kif ġej:
English: NAME OF THE MEDICINAL PRODUCT Focetria suspension for injection in pre-filled syringe Influenza vaccine H1N1v (surface antigen, inactivated, adjuvanted)
Maltese: Focetria suspensjoni għall-injezzjoni f'siringa mimlija għal-lest Vaċċin kontra l-influwenza H1N1v (antiġeni tal-wiċċ, inattivati, adjuvantat)
English: Focetria can be given at the same time as non-adjuvanted seasonal influenza vaccines, with injections made into separate limbs.
Maltese: Focetria jista' jingħata fl-istess ħin ma' vaċċini tal-influwenza staġjonali mhux adjuvantati, b'injezzjonijiet isiru f'dirgħajn separati.
English: It is provided in: - a ready-to-use syringe, containing a single dose of 0.5 ml for injection; - vial containing ten doses of 0.5 ml each for injection.
Maltese: Huwa fornut - f'siringa lesta għall-użu li tesa' doża waħda ta' 0.5 ml għall-injezzjoni; - kunjett li fih għaxar dożi ta' 0.5 ml kull waħda għall-injezzjoni.
English: Taking into account the PRAC Assessment Report on the PSUR for Focetria, the scientific conclusions of PRAC are as follows:
Maltese: Meta ġie kkunsidrat ir-Rapport ta' Valutazzjoni ta' PRAC dwar il-PSUR għal Foceria, il-konklużjonijiet xjentifiċi ta' PRAC huma kif ġej:
English: The seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody to H1N1v in children aged 3-8 years by HI assay after administration of 7.5 µg of Focetria were as follows:
Maltese: Ir-rata ta' seroprotezzjoni*, rata ta' serokonverżjoni* u l-fattur ta' serokonverżjoni** għal antikorp anti HA għal H1N1v fi tfal u adoloxxenti ta' bejn it-3 snin u t-8 snin b'assaġġ HI wara għoti ta' 7.5 µg ta' Focetria kienu kif ġej:
English: The seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody to H1N1v in infants aged 6-11 months by HI assay after administration of 7.5 µg of Focetria were as follows:
Maltese: Ir-rata ta' seroprotezzjoni*, rata ta' serokonverżjoni* u l-fattur ta' serokonverżjoni** għall-antikorp anti-HA għall-H1N1v fi trabi ta' bejn 6-11-il xahar b'assaġġ IH wara l-għoti ta' 7.5 µg ta' Focetria kienu kif ġej:
English: The other ingredients are: thiomersal (multidose vial only), sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, sodium citrate, citric acid and water for injections.
Maltese: Is-sustanzi l-oħra huma: thiomersal (f'kunjett ta' diversi dożi biss), sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, sodium citrate, citric acid u ilma għall-injezzjonijiet.
English: INFORMATION IN BRAILLE Justification for not including Braille accepted
Maltese: Il-Ġustifikazzjoni biex ma jkunx inkluż il-Braille hija aċċettata
English: • The MAH shall agree with Member States to measures facilitating the identification and traceability of the A/H1N1 vaccine administered to each patient, in order to minimise medication errors and aid patients and health care professionals to report adverse reactions.
Maltese: • Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq kif maqbul mal-Istati Membri għandu jkollu l-miżuri li jiffaċilitaw l-identifikazzjoni u traċċabilità tal-vaċċin A/H1N1 li jingħata lil kull pazjent, sabiex jiġu minimizzati żbalji fl-amministrazzjoni u pazjenti u professjonisti fil-qasam tal-kura tas-saħħa jiġu mgħejjuna jirraportaw reazzjonijiet avversi.
English: Very commonly reported reactions in both children and adolescents were pain, hardening of the skin at the injection site, injection site redness, generally feeling unwell, muscle ache, headache and fatigue.
Maltese: Reazzjonijiet irrappurtati b'mod komuni ħafna kemm fit-tfal kif ukoll fl-adoloxxenti kienu wġigħ, twebbis tal-ġilda fis-sit tal-injezzjoni, ħmura fis-sit tal-injezzjoni, sensazzjoni ġenerali li ma tiflaħx, uġigħ fil-muskoli, uġigħ ta' ras u għeja.
English: Other medicines and Focetria
Maltese: KIF TAĦŻEN FOCETRIA
English: The immune response to the seasonal antigens was satisfactory.
Maltese: Ir-rispons immunitarju għall-antiġens staġjonali kien sodisfaċenti.
English: How to store FOCETRIA
Maltese: Rispons immuni għal Focetria
English: You should discuss with your doctor whether you should receive Focetria taking into consideration official recommendation based on post-marketing reported adverse events during second and third trimesters of pregnancy.
Maltese: Inti għandek tiddiskuti mat-tabib tiegħek jekk għandekx tieħu Focetria meta tikkunsidra r-rakkomandazzjoni uffiċjali bbażata fuq l-avvenimenti avversi rrappurtati wara t-tqegħid fis-suq matul it-tieni u t-tielet trimestru tat-tqala.
English: The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1 of the marketing authorisation, is in place and functioning before the product is placed on the market and for as long as the marketed product remains in use.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq irid jiżgura li s-sistema ta' farmakoviġilanza, ippreżentata f'Modulu 1.8.1 awtorizzazzjoni għat-tqegħid fis-suq, tkun implimentata u tkun taħdem qabel ma l-prodott jibda jinbiegħ, u sakemm il-prodott li jkun qiegħed fis-suq jibqa' jintuża.
English: Name and address of the manufacturer(s) responsible for batch release
Maltese: Isem u indirizz tal-manifattur responsabbli għall-ħruġ tal-lott
English: Anti-HA antibody
Maltese: Effetti sekondarji oħrajn
English: Immunogencity results with two doses of 7.5 µg Focetria H1N1v vaccine from the ongoing clinical trial in adults and elderly are shown below.
Maltese: H1N1v fi studji kliniċi jissuġġerixxi li doża waħda tista' tkun biżżejjed.
English: These side effects may occur with Focetria.
Maltese: Dawn l-effetti sekondarji jistgħu jseħħu b'Focetria.
English: The full EPAR for Signifor can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The active substance in Signifor, pasireotide is a somatostatin analogue.
Maltese: Is-sustanza attiva f'Signifor, il-pasireotide hija analogu tas-somatostatina.
English: It contains the active substance pasireotide.
Maltese: Dan fih is-sustanza attiva pasireotide.
English: Other information about Signifor
Maltese: Informazzjoni oħra dwar Signifor
English: Pre-defined levels were less than 2.5 micrograms/liter for growth hormone or within normal limits for IGF-1.
Maltese: Il-livelli predefiniti kienu inqas minn 2.5 mikrogramma/litru għall-ormon tat-tkabbir jew fil-limiti normali għal IGF-1.
English: (To reduce cortisol, pasireotide first reduces the production of another hormone ACTH, which controls cortisol production.)
Maltese: (Sabiex jitnaqqas cortisol, il-pasireotide l-ewwel tnaqqas il-produzzjoni ta' ormon ieħor ACTH, li jikkontrolla l-produzzjoni ta' cortisol.)
English: This is a summary of the European public assessment report (EPAR) for Signifor.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Signifor.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Signifor on 24 April 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Signifor fl-24 ta' April 2012.
English: In the second study in 198 patients whose disease had not been adequately controlled with surgery or other medical treatment, 15% of patients receiving Signifor 40 mg and 20% of patients receiving Signifor 60 mg achieved pre-defined reductions in hormone levels after 24 weeks, compared with none of the 68 patients given the somatostatin analogues octreotide or lanreotide.
Maltese: Ft-tieni studju f'198 pazjent li l-marda tagħhom ma ġietx ikkontrollata b'mod adegwat bil-kirurġija jew b'kura medika oħra, 15 % tal-pazjenti li kienu qed jirċievu Signifor 40 mg u 20 % tal-pazjenti li kienu qed jirċievu Signifor 60 mg kisbu tnaqqis predefinit fil-livelli tal-ormon wara 24 ġimgħa, meta mqabbel ma' ħadd mit-68 pazjent li ngħataw l-analogi tas-somatostatina octreotide jew lanreotide.
English: What are the risks associated with Signifor?
Maltese: X'inhuma r-riskji assoċjati ma' Signifor?
English: In a main study in 358 previously untreated adults, 31% of patients receiving Signifor had their growth hormone and IGF-1 levels reduced to pre-defined low levels after 1 year, compared with 19% of patients receiving octreotide, another somatostatin analogue.
Maltese: Fi studju ewlieni fi 358 pazjent adult li ma ġewx ikkurati preċedentement, 31 % tal-pazjenti li kienu qed jirċievu Signifor kellhom il-livelli tagħhom tal-ormon tat-tkabbir u ta' IGF-1 jonqsu għal livelli baxxi predefiniti wara sena, meta mqabbel ma' 19 % tal-pazjenti li kienu qed jirċievu octreotide, analogu ieħor tas-somatostatina.
English: The most common side effects with Signifor (seen in more than 1 patient in 10) are hyperglycaemia (high blood sugar levels), diabetes, diarrhoea, abdominal pain (stomach ache), nausea (feeling sick),
Maltese: L-effetti sekondarji l-aktar komuni b'Signifor (li dehru f'aktar minn pazjent 1 minn kull 10) huma ipergliċemija (livelli għoljin taz-zokkor fid-demm), dijabete, dijarea, uġigħ addominali (uġigħ flistonku), nawżja (tħossok ma tiflaħx), kolelitjażi (ġebel fil-marrara), reazzjonijiet fis-sit tal-injezzjoni, u għeja.
English: This means that it works in the same way as the natural hormone, somatostatin, to block the release of growth hormone from the pituitary glands located at the base of the brain and indirectly block the release of cortisol from the adrenal gland found above the kidneys.
Maltese: Signifor jiġi bħala soluzzjoni għall-injezzjoni taħt il-ġilda u bħala trab u likwidu li jintużaw għallinjezzjoni ġol-muskolu.
English: Signifor is effective in reducing levels of growth hormone and IGF-1 (another hormone that is elevated in acromegaly patients).
Maltese: Signifor huwa effikaċi biex inaqqas il-livelli tal-ormon tat-tkabbir u ta' IGF-1 (ormon ieħor li jkun għoli f'pazjenti bl-akromegalija).
English: In a main study in 165 adult patients who were given the injection under the skin, 15% of patients receiving 0.6 mg Signifor and 26% of patients receiving 0.9 mg Signifor had normal urine cortisol levels within 6 months.
Maltese: Fi studju ewlieni f'165 pazjent adult li ngħataw l-injezzjoni taħt il-ġilda, 15 % tal-pazjenti li kienu qed jirċievu 0.6 mg Signifor u 26 % tal-pazjenti li kienu qed jirċievu 0.9 mg Signifor kellhom livelli ta' cortisol normali fl-awrina fi żmien 6 xhur. 34 % tal-pazjenti li kienu qed jirċievu 0.6 mg Signifor u 41 % talpazjenti li kienu qed jirċievu 0.9 mg Signifor irrispondew parzjalment għall-kura, bil-livelli ta' cortisol flawrina tagħhom jonqsu bin-nofs fi żmien 6 xhur.
English: Signifor is a medicine for treating adults with Cushing's disease (a condition caused by too much of a hormone called cortisol) and acromegaly (excessive growth, particularly of bones in the hands, feet and face caused by too much growth hormone).
Maltese: Signifor huwa mediċina għall-kura tal-adulti bil-marda ta' Cushing (kondizzjoni kkawżata minn eċċess tal-ormon li jissejjaħ cortisol) u akromegalija (tkabbir eċċessiv, b'mod partikolari tal-għadam fl-idejn, fis-saqajn u fil-wiċċ ikkawżat minn eċċess tal-ormon tat-tkabbir).
English: Although the number of patients whose cortisol levels returns to normal is small, Signifor is expected tp help patients whose surgical treatments have failed or who cannot have surgery.
Maltese: Għalkemm in-numru ta' pazjenti li l-livelli ta' cortisol tagħhom jirritornaw għan-normal huwa żgħir, Signifor huwa mistenni li jgħin lill-pazjenti li l-kuri kirurġiċi tagħhom ma ħadmux jew li ma tistax issirilhom kirurġija.
English: For the full list of restrictions with Signifor, see the package leaflet.
Maltese: Għal-lista sħiħa ta' restrizzjonijiet b'Signifor, ara l-fuljett ta' tagħrif.
English: How is Signifor used?
Maltese: -użu ta' Signifor.
English: For acromegaly, Signifor is given as an injection into the buttock muscle every 4 weeks.
Maltese: Għall-akromegalija, Signifor jingħata bħala injezzjoni ġol-muskolu tal-warrani kull 4 ġimgħat.
English: Because the numbers of patients with these diseases are low, the diseases are considered ‘rare', and Signifor was designated an ‘orphan medicine' (a medicine used in rare diseases).
Maltese: Peress li n-numru ta' pazjenti li jbatu minn dan il-mard huwa baxx, il-mard huwa kkunsidrat ‘rari', u Signifor ġie kklassifikat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari).
English: Why is Signifor approved?
Maltese: Għaliex ġie approvat Signifor?
English: The summaries of the opinions of the Committee for Orphan Medicinal Products for Signifor can be found on the Agency's website:
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni għal Signifor jinstab fis-sit elettroniku tal-Aġenzija:
English: Signifor is effective at reducing elevated cortisol levels patients with Cushing's disease.
Maltese: Signifor huwa effettiv biex inaqqas il-livelli għoljin ta' cortisol f'pazjenti bil-marda ta' Cushing.
English: In a second study in 150 adult patients which used the muscle injection, around 41% of patients responded to treatment within 7 months.
Maltese: Fit-tieni studju f'150 pazjent adult li użaw l-injezzjoni ġol-muskolu, madwar 41 % tal-pazjenti rrispondew għall-kura fi żmien 7 xhur.
English: Signifor is effective at normalising cortisol levels in some patients with Cushing's disease.
Maltese: Signifor huwa effettiv biex jinnormalizza l-livelli ta' cortisol f'xi pazjenti bil-marda ta' Cushing.
English: What measures are being taken to ensure the safe and effective use of Signifor?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Signifor?
English: In patients with Cushing's disease, Signifor is given as an injection either under the skin (preferably at the top of the thigh and the belly) twice a day or into the buttock muscle every 4 weeks.
Maltese: F'pazjenti bil-marda ta' Cushing, Signifor jingħata bħala injezzjoni jew taħt il-ġilda (preferibbilment filparti ta' fuq tal-koxxa u taż-żaqq) darbtejn kuljum jew ġol-muskolu tal-warrani kull 4 ġimgħat.
English: Signifor is used for these conditions when surgery has failed or is not possible and, in the case of acromegaly, when the condition is also not adequately controlled with other medicines similar to Signifor known as ‘somatostatin analogues'.
Maltese: Signifor jintuża għal dawn il-kondizzjonijiet meta l-kirurġija ma tkunx ħadmet jew ma tkunx possibbli u, f'każ ta' akromegalija, meta l-kondizzjoni lanqas ma tiġi kkontrollata b'mod adegwat b'mediċini oħra simili għal Signifor magħrufa bħala “analogi ta' somastatina”.
English: For the full list of all side effects reported with Signifor, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Signifor, ara l-fuljett ta
English: How does Signifor work?
Maltese: Kif jaħdem Signifor?
English: The full EPAR for Zycortal can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Desoxycortone pivalate
Maltese: Desoksikorton pivalat
English: Zycortal contains the active substance desoxycortone pivalate.
Maltese: Zycortal fih is-sustanza attiva desoksikorton pivalat.