FrancophonIA/ELRC3.0 huggingface dataset:
English: • Calculate and write down the remaining dose to inject in column C by subtracting the number in column B from the number in column A. Use a calculator to check your math if needed.
Maltese: • Ikkalkula u ikteb id-doża li jkun fadal biex tiġi injettata f'kolonna C billi tnaqqas in-numru f'kolonna B min-numru f'kolonna A.
English: REKOVELLE is used in the treatment of female infertility and in women undergoing assisted reproduction programmes such as in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI).
Maltese: (IVF, in vitro fertilisation) jew ċiklu ta' injezzjoni ta' sperma intraċitoplażmatika (ICSI, intracytoplasmic sperm injection).
English: • you have fibroids of the uterus which make a normal pregnancy impossible.
Maltese: • jekk int għandek fibrojdi fl-utru, li jagħmlu tqala normali impossibbli
English: REKOVELLE 72 micrograms/2.16 mL solution for injection follitropin delta
Maltese: REKOVELLE 72 mikrogramma/2.16 ml soluzzjoni għall-injezzjoni follitropin delta
English: Sodium content REKOVELLE contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”.
Maltese: REKOVELLE fih anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles mis sodium'.
English: The resulting REKOVELLE dosing regimen is in section 4.2.
Maltese: Prodott, sezzjoni 4.2).
English: Sodium sulphate decahydrate Disodium phosphate dodecahydrate Phosphoric acid, concentrated (for pH-adjustment) Sodium hydroxide (for pH-adjustment) Water for injections
Maltese: Sodium sulphate decahydrate Disodium phosphate dodecahydrate
English: Mood swings
Maltese: Skumdità pelvika
English: Injecting the dose - (Step 11 to 12)
Maltese: Kif tinjetta d-doża - (Pass 11 sa 12) Importanti:
English: REKOVELLE 36 micrograms/1.08 mL solution for injection follitropin delta
Maltese: REKOVELLE 36 mikrogramma/1.08 ml soluzzjoni għall-injezzjoni follitropin delta
English: Disposal of Needle - (Step 13)
Maltese: Kif Tarmi l-Labra - (Pass 13)
English: Write down your prescribed dose in column A.
Maltese: Ikteb id-doża tiegħek li għaliha ngħatajt riċetta f'kolonna A.
English: PHARMACEUTICAL FORM Solution for injection (injection).
Maltese: intracytoplasmic sperm injection).
English: The pharmacokinetic profile of follitropin delta has been investigated in healthy female subjects and in IVF/ICSI patients undergoing COS.
Maltese: Il-profil farmakokinetiku ta' follitropin delta ġie investigat f'individwi nisa b'saħħithom u f'pazjenti IVF/ICSI li kienet qed issirilhom COS.
English: Ferring GmbH Wittland 11
Maltese: Wittland 11
English: REKOVELLE 72 micrograms/2.16 mL solution for injection One pre-filled multidose pen delivers 72 micrograms follitropin delta* in 2.16 mL solution.
Maltese: REKOVELLE 72 mikrogramma/2.16 ml soluzzjoni għall-injezzjoni Skartoċċ wieħed b'ħafna dożi fih 72 mikrogramma ta' follitropin delta* f'soluzzjoni ta' 2.16 ml.
English: Needles
Maltese: Dardir
English: Split-dosing:
Maltese: TAL-PRODOTT
English: The number of oocytes retrieved increases with the dose of REKOVELLE and serum AMH concentration.
Maltese: In-numru ta' ooċiti miksubin jiżdied mad-doża tal-konċentrazzjoni ta' REKOVELLE u AMH fis serum.
English: It comprises marked ovarian enlargement, high serum sex steroids, and an increase in vascular permeability which can result in an accumulation of fluid in the peritoneal, pleural and, rarely, in the pericardial cavities.
Maltese: Tinkludi tkabbir notevoli tal-ovarji, ammont għoli ta' sterojdi tas-sess fis-serum, u żieda fil-permeabilità vaskulari li tista' tirriżulta f'akkumulazzjoni ta' likwidu fl-ispazji peritoneali, plewrali, u, b'mod rari, f'dawk perikardjali.
English: In use: 28 days when stored at or below 25 °C.
Maltese: Waqt l-użu: 28 jum meta jinħażen f'temperatura ta', jew taħt 25 °C.
English: Each cartridge contains 0.36 mL of solution.
Maltese: Kull skartoċċ fih 0.36 mL ta' soluzzjoni.
English: Safety, efficacy and pharmacokinetics of REKOVELLE in patients with renal or hepatic impairment have not been specifically studied in clinical trials.
Maltese: Is-sigurtà, l-effikaċja u l-farmakokinetika ta' REKOVELLE f'pazjenti b'indeboliment tal-kliewi jew tal-fwied ma ġewx studjati speċifikament fil-provi kliniċi.
English: The dose should be based on a recent determination of AMH (i.e. within the last 12 months) measured by the following diagnostic test from Roche: ELECSYS AMH Plus immunoassay (see section 4.4).
Maltese: Immunoassaġġ ta' ELECSYS AMH Plus (ara sezzjoni 4.4).
English: Dialing the dose - (Step 10)
Maltese: Kif tiddajalja d-doża - (Pass 10)
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 72 mcg/2.16 mL
Maltese: IL-KONTENUT SKONT IL-PIŻ, IL-VOLUM, JEW PARTI INDIVIDWALI 72 mcg/2.16 ml
English: Follitropin delta leads to greater exposure than follitropin alfa.
Maltese: Follitropin delta iwassal għal esponiment akbar minn follitropin alfa.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION REKOVELLE 72 micrograms/2.16 mL injection follitropin delta
Maltese: REKOVELLE injezzjoni ta' 72 mikrogramma/2.16 ml follitropin delta
English: REKOVELLE 36 micrograms/1.08 mL solution for injection One pre-filled multidose pen delivers 36 micrograms follitropin delta* in 1.08 mL solution.
Maltese: REKOVELLE 36 mikrogramma/1.08 ml soluzzjoni għall-injezzjoni Skartoċċ wieħed b'ħafna dożi fih 36 mikrogramma ta' follitropin delta* f'soluzzjoni ta' 1.08 ml.
English: The prevalence of ectopic pregnancy after ART has been reported to be higher than in the general population.
Maltese: Il-prevalenza ta' tqala ektopika wara ART, ġiet irrappurtata li hi ogħla meta mqabbla mal-popolazzjoni ġenerali.
English: Other medicines and REKOVELLE
Maltese: Mediċini oħra u REKOVELLE
English: REKOVELLE 12 micrograms/0.36 mL solution for injection One pre-filled multidose pen delivers 12 micrograms follitropin delta* in 0.36 mL solution.
Maltese: REKOVELLE 12-il mikrogramma/0.36 ml soluzzjoni għall-injezzjoni Skartoċċ wieħed b'ħafna dożi fih 12-il mikrogramma ta' follitropin delta* f'soluzzjoni ta' 0.36 ml.
English: Renal and hepatic impairment REKOVELLE has not been studied in patients with moderate/severe renal or hepatic impairment.
Maltese: REKOVELLE ma ġiex studjat f'pazjenti b'indeboliment moderat/sever tal-kliewi jew tal-fwied.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 36 mcg/1.08 mL
Maltese: INDIVIDWALI 36 mcg/1.08 ml
English: When undergoing assisted reproductive technology treatment, you are more likely to have a miscarriage than if you conceive naturally.
Maltese: Meta tkun qed tirċievi kura b'teknoloġija riproduttiva assistita, hu aktar probabbli li jkollok korriment milli jekk toħroġ tqila b'mod naturali.
English: REKOVELLE is designed for use in conjunction with the REKOVELLE injection pen provided separately.
Maltese: REKOVELLE hu maħsub għall-użu flimkien mal-pinna tal-injezzjoni REKOVELLE ipprovduta separatament.
English: The cartridge may be used for several injections.
Maltese: L-iskartoċċ jista' jintuża għal diversi injezzjonijiet.
English: NAME OF THE MEDICINAL PRODUCT REKOVELLE 36 micrograms/1.08 mL solution for injection follitropin delta
Maltese: REKOVELLE injezzjoni ta' 36 mikrogramma/1.08 ml follitropin delta
English: • you have a tumour of the uterus, ovaries, breasts, pituitary gland or hypothalamus
Maltese: • jekk int għandek tumur tal-utru, tal-ovarji, tas-sider, tal-glandola pitwitarja jew tal-ipotalamu
English: • made of a heavy-duty plastic,
Maltese: • magħmul minn plastik b'saħħtu,
English: Polycystic ovarian syndrome patients with anovulatory disorders Anovulatory patients with polycystic ovarian syndrome have not been studied.
Maltese: Pazjenti anovulatorji b'sindrome poliċistiku tal-ovarji ma ġewx studjati.
English: Step 1:
Maltese: Pass 2:
English: • Vaginal bleeding
Maltese: • int imdardra
English: Vomiting
Maltese: Fertilità
English: The apparent clearance for follitropin delta is low, i.e. 0.6 L/h after multiple subcutaneous administration, leading to high exposure.
Maltese: It-tneħħija apparenti għal follitropin delta hi baxxa, i.e. 0.6 L/h wara għoti multiplu taħt il-ġilda, li jwassal għal esponiment għoli.
English: E.J.
Maltese: L-UŻU
English: Follitropin delta had a negative effect on fertility and early embryonic development in rats when administered in doses ≥0.8 micrograms/kg/day which is above the recommended maximal dose in humans.
Maltese: Follitropin delta kellu effett negattiv fuq il-fertilità u l-iżvilupp bikri embrijoniku fil-firien meta ngħata f'dożi ta' ≥0.8 mikrogrammi/kg/jum, li huma ogħla mid-doża massima rakkomandata fil-bnedmin.
English: For women with AMH ≥15 pmol/L the daily dose decreases from 0.19 to 0.10 micrograms/kg by increasing AMH concentration (Table 1).
Maltese: kuljum tonqos minn 0.19 għal 0.10 mikrogramma/kg skont iż-żieda fil-konċentrazzjoni ta' AMH
English: Cleaning
Maltese: Dijarea
English: NAME OF THE MEDICINAL PRODUCT REKOVELLE 12 micrograms/0.36 mL solution for injection follitropin delta
Maltese: REKOVELLE injezzjoni ta' 12-il mikrogramma/0.36 ml follitropin delta
English: Following subcutaneous administration, the apparent clearance of follitropin delta is 0.6 L/h and the clearance after intravenous is 0.3 L/h.
Maltese: Wara l-għoti taħt il-ġilda, it-tneħħija apparenti ta' follitropin delta hi ta' 0.6 L/h u t-tneħħija wara l-lgħoti ġol-vini hi ta' 0.3 L/h.
English: Step 2: • Pull off the pen cap.
Maltese: Pass 4: • Ikklikkja fuq il-labra.
English: Dose to dial on pen
Maltese: Tagħmlux fil-friża.
English: It is available in packs of 1 cartridge and 6 pen injection needles.
Maltese: Hu disponibbli f'pakketti ta' 1 skartoċċ u 6 labriet tal-injezzjoni bil-pinna.
English: It is available in packs of 1 cartridge and 9 pen injection needles.
Maltese: Hu disponibbli f'pakketti ta' 1 skartoċċ u 9 labriet tal-injezzjoni bil-pinna.
English: Each cartridge contains 1.08 mL of solution.
Maltese: Kull skartoċċ fih 1.08 mL ta' soluzzjoni.
English: The fraction of follitropin delta excreted unchanged in the urine was estimated to 9%.
Maltese: Il-frazzjoni ta' follitropin delta li titneħħa mhux mibdula fl-awrina, ġiet stmata li hi ta' 9%.
English: • Do not inject into an area that is sore (tender), bruised, red, hard, scarred or where you have stretch marks.
Maltese: • Tinjettax f'żona li tkun bl-uġigħ (sensittiva), imbenġla, ħamra, iebsa, biċ-ċikatriċi jew fejn ikollok stretch marks.
English: • tumours of the hypothalamus or pituitary gland
Maltese: • ikollok diffikultà biex tieħu n-nifs
English: Dose display window for example of prescribed dose
Maltese: SIGUR U EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: Each cartridge contains 2.16 mL of solution.
Maltese: Kull skartoċċ fih 2.16 mL ta' soluzzjoni.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and local tolerance.
Maltese: Tagħrif mhux kliniku ibbażat fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn dożi ripetuti u tolleranza lokali, ma juri l-ebda periklu speċjali għall-bnedmin.
English: After first use (in-use period): • The pen may be stored for up to 28 days at 2°C to 25°C.
Maltese: • Il-pinna tista' tinħażen għal massimu ta' 28 jum f'temperatura ta' bejn 2°C sa 25°C.
English: • This medicine should be given by injection just under the skin (subcutaneously) in the stomach-area (abdomen).
Maltese: • Din il-mediċina għandha tingħata permezz ta' injezzjoni eżatt taħt il-ġilda (b'mod subkutanju)
English: PC:
Maltese: Tālr:
English: The prevalence of congenital malformations after ART may be slightly higher than after spontaneous conceptions.
Maltese: ART tista' tkun ftit ogħla minn dawk ta' wara konċepimenti spontanji.
English: Instructions for use - REKOVELLE (follitropin delta) pre-filled pen
Maltese: Poġġi f'postu l-għatu tal-pinna - (Pass 14)
English: Vaginal haemorrhage Breast pain Breast tenderness
Maltese: Sindrome poliċistiku tal-ovarji f'pazjenti b'disturbi anovulatorji
English: These rates were similar to the incidence of pre-existing anti-FSH antibodies before exposure to REKOVELLE in cycle 1 which was 1.4%, and comparable to the incidences of anti-FSH antibodies after treatment with follitropin alfa.
Maltese: Dawn ir rati kienu simili għall-inċidenza ta' antikorpi kontra FSH li kienu jeżistu minn qabel, qabel lesponiment għal REKOVELLE f'ċiklu 1, li kienet ta' 1.4%, u kienet komparabbli għall-inċidenzi ta'
English: Why do I have to count to 5 while holding the injection button?
Maltese: Għaliex għandi ngħodd sa 5 waqt li nżomm il-buttuna tal-injezzjoni?
English: Before use:
Maltese: Tużax REKOVELLE:
English: REKOVELLE contains a potent gonadotropic substance capable of causing mild to severe adverse reactions, and should only be used by physicians who are thoroughly familiar with infertility problems and their management.
Maltese: REKOVELLE fih sustanza gonadotropika potenti li kapaċi tikkawża reazzjonijiet avversi minn ħfief sa severi, u għandu jintuża biss minn tobba li huma familjari sewwa ma' problemi tal-infertilità u limmaniġġjar tagħhom.
English: Attaching needle - (Step 2 to 6)
Maltese: Kif twaħħal il-labra - (Pass 2 sa 6) Importanti:
English: The incidence of pregnancy loss by miscarriage or abortion is higher in patients undergoing controlled ovarian stimulation for ART than following natural conception.
Maltese: L-inċidenza ta' telf ta' tqala minħabba korriment jew abort hu ogħla fil-pazjenti li jkunu qed jirċievu stimulazzjoni kkontrollata tal-ovarji għal ART milli minn konċepiment naturali.
English: In patients with excessive follicular development (of ≥25 follicles ≥12 mm), treatment with REKOVELLE should be stopped and triggering of final follicular maturation with hCG should not be performed.
Maltese: (ta' ≥25 follikulu ta' ≥12 mm), il-kura b'REKOVELLE għandha titwaqqaf u l-istimulazzjoni tal maturazzjoni follikulari finali b'hCG m'għandux jitwettaq.
English: REKOVELLE pre-filled pen follitropin delta
Maltese: Istruzzjonijiet Għall-Użu REKOVELLE pinna mimlija għal-lest follitropin delta
English: Keep the cartidge in the REKOVELLE injection pen.
Maltese: Armi labar użati immedjatament wara l injezzjoni.
English: There have been reports of ovarian and other reproductive system tumours in women who had undergone infertility treatment.
Maltese: Kien hemm rapporti ta' tumuri tal-ovarji u tumuri oħrajn tas-sistema riproduttiva f'nisa li rċivew kura għall-infertilità.
English: Known gastrointestinal symptoms associated with OHSS include abdominal pain, discomfort, and distension, nausea, vomiting and diarrhoea.
Maltese: Sintomi gastrointestinali magħrufa assoċjati ma' OHSS jinkludu wġigħ addominali, skonfort, u nefħa, dardir, rimettar u dijarea.
English: For storage conditions after first use of the medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara l-ewwel użu tal-prodott mediċinali, ara sezzjoni 6.3.
English: REKOVELLE 12 micrograms/0.36 mL solution for injection 3 mL multidose cartridge (Type I glass) with a plunger (halobutyl rubber) and a crimp cap (aluminium) with an inlay (rubber).
Maltese: Skartoċċ ta' 3 ml b'ħafna dożi (ħġieġ ta' Tip I) bi planġer (lastiku tal-halobutyl) u crimp cap
English: This is thought to be due to differences in parental characteristics (e.g. maternal age, sperm characteristics) and multiple pregnancy.
Maltese: l-età tal-omm, karatteristiċi tal-isperma) u tqala multipla.
English: Excessive ovarian response to gonadotropin treatment seldom gives rise to OHSS unless hCG is administered to trigger final follicular maturation.
Maltese: Rispons eċċessiv tal-ovarji għal kura b'gonadotropins, rari jikkawża OHSS ħlief jekk hCG jingħata biex jistimula il-maturazzjoni follikulari finali.
English: Repeated treatment with REKOVELLE of patients with pre-existing or treatment-induced anti-FSH antibodies did not increase the antibody titre, was not associated with decreased ovarian response, and did not induce immune-related adverse events.
Maltese: Kura ripetuta b'REKOVELLE ta' pazjenti b'antikorpi kontra FSH li kienu jeżistu minn qabel, jew li żviluppaw mill-kura, ma żiditx it-titer tal-antikorpi, ma kinitx assoċjata ma' tnaqqis fir-rispons tal-ovarji, u ma kkawżatx avvenimenti avversi relatati mal-immunità.
English: Pregnancy outside the uterus (ectopic pregnancy)
Maltese: Tqala barra mill-utru (tqala ektopika)
English: It is available in packs of 1 cartridge and 3 pen injection needles.
Maltese: Hu disponibbli f'pakketti ta' 1 skartoċċ u 3 labriet tal-injezzjoni bil-pinna.
English: When undergoing assisted reproductive technology treatment, you are more likely to have a pregnancy outside the uterus (ectopic pregnancy) than if you conceive naturally.
Maltese: Meta tkun qed tirċievi kura b'teknoloġija riproduttiva assistita, hu aktar probabbli li jkollok tqala barra mill-utru (tqala ektopika) milli jekk toħroġ tqila b'mod naturali.
English: EMA/685570/2018 EMEA/H/C/002202
Maltese: EMA/685570/2018 EMA/H/C/002202
English: Gilenya is available as capsules (0.25 mg and 0.5 mg).
Maltese: Gilenya jiġi bħala kapsuli (0.25 mg u 0.5 mg).
English: Further information on Gilenya can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Gilenya.
Maltese: ema.europa.eu/medicines/human/EPAR/Gilenya.
English: Gilenya contains the active substance fingolimod.
Maltese: Gilenya fih is-sustanza attiva fingolimod.
English: Of patients given Gilenya, 14% (15 out of 107) experienced relapses compared with 54% (58 out of 107) of patients given interferon beta-1a.
Maltese: Mill-pazjenti li ngħataw Gilenya, 14 % (15 minn 107) esperjenzaw rikaduti meta mqabbla ma' 54 % (58 minn 107) tal-pazjenti li ngħataw interferon beta-1a.
English: Gilenya received a marketing authorisation valid throughout the EU on 17 March 2011.
Maltese: Gilenya ngħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fis-17 ta' Marzu 2011.
English: Other information about Gilenya
Maltese: Informazzjoni oħra dwar Gilenya
English: In a third study involving 1,292 patients, Gilenya was compared with interferon beta-1a over one year.
Maltese: Fit-tielet studju li involva 1 292 pazjent, Gilenya tqabbel ma' interferon beta-1a fuq perjodu ta' sena.
English: The most common side effects with Gilenya (seen in more than 1 patient in 10) are flu, sinusitis (inflammation of the sinuses), headache, cough, diarrhoea, back pain and raised liver enzyme levels (a sign of liver problems).
Maltese: L-effetti sekondarji l-aktar komuni b'Gilenya (li dehru f'aktar minn pazjent 1 minn kull 10) huma influwenza, sinusite (infjammazzjoni tas-sinus), uġigħ ta' ras, sogħla, dijarea, uġigħ fid-dahar u livelli għoljin ta' enzimi tal-fwied (sinjal ta' problemi fil-fwied).
English: In two studies involving a total of 2,355 patients, Gilenya was compared with placebo over two years.
Maltese: F'żewġ studji li involvew total ta' 2 355 pazjent, Gilenya tqabbel mal-plaċebo fuq perjodu ta' sentejn.
English: Gilenya is a type of medicine known as a ‘disease-modifying therapy' that is used to treat adults and children over 10 years of age with highly active relapsing-remitting multiple sclerosis (MS), a disease of the nerves in which inflammation destroys the protective sheath surrounding the nerve cells.
Maltese: Gilenya huwa tip ta' mediċina msejħa “terapija li timmodifika l-marda” li tintuża biex tikkura adulti u tfal li għandhom aktar minn 10 snin bi sklerożi multipla (SM) rikaduta-remittenti attiva ħafna, marda tan-nervituri fejn l-infjammazzjoni teqred is-saff protettiv madwar iċ-ċelloli tan-nervituri. ‘Rikadutaremittenti' tfisser li l-pazjent ikollu feġġiet ta' sintomi (rikaduti) segwiti minn perjodi ta' rkupru (remissjonijiet).
English: Three main studies in adults and one main study in children have found that Gilenya was more effective than placebo (a dummy treatment) or interferon beta-1a (another medicine for treating multiple sclerosis) in patients with relapsing-remitting multiple sclerosis.
Maltese: Tliet studji ewlenin fl-adulti u wieħed ewlieni fit-tfal sabu li Gilenya kien aktar effettiv mill-plaċebo (kura finta) jew minn interferon beta-1a (mediċina oħra għall-kura tal-isklerożi multipla) f'pazjenti bi sklerożi multipla rikaduta-remittenti.
English: The most serious side effects are infections, macular oedema (swelling in the central part of the retina at the back of the eye) and atrioventricular block (a type of heart rhythm disorder) at the start of treatment.
Maltese: L-effetti sekondarji l-aktar serji huma infezzjonijiet, edema makulari (nefħa fil-parti ċentrali tar-retina fuq wara tal-għajn) u blokk atrijoventrikulari (tip ta' disturb fir-ritmu tal-qalb) fil-bidu tal-kura.
English: As for all medicines, data on the use of Gilenya are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Gilenya hija ssorveljata kontinwament.
English: Why is Gilenya authorised in the EU?
Maltese: Għaliex Gilenya huwa awtorizzat fl-UE?
English: For the full list of side effects of Gilenya, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji ta' Gilenya, ara l-fuljett ta' tagħrif.
English: The recommended dose for adults is one 0.5 mg capsule taken once a day by mouth, the recommended dose for children depends on body weight.
Maltese: Id-doża rakkomandata għall-adulti hi kapsula waħda ta' 0.5 mg meħuda darba kuljum mill-ħalq, id-doża rakkomandata għat-tfal tiddependi mill-piż tal-ġisem.
English: Patients receiving Gilenya had around half the number of relapses compared with patients given interferon beta-1a.
Maltese: Il-pazjenti li kienu qegħdin jirċievu Gilenya kellhom madwar nofs in-numru ta' rikaduti meta mqabbla ma' pazjenti li ngħataw interferon beta-1a.
English: What are the risks associated with Gilenya?
Maltese: X'inhuma r-riskji assoċjati ma' Gilenya?
English: In multiple sclerosis, the immune system (the body's defences) incorrectly attacks the protective sheath around the nerves in the brain and spinal cord.
Maltese: Fl-isklerożi multipla, is-sistema immunitarja (id-difiżi tal-ġisem) tattakka b'mod ħażin lir-rita protettiva madwar in-nervituri fil-moħħ u fis-sinsla tad-dahar.
English: The active substance in Gilenya, fingolimod, prevents T cells (a type of white blood cell involved in the immune system) travelling from the lymph nodes towards the brain and spinal cord, thus limiting the damage they cause in multiple sclerosis.
Maltese: Is-sustanza attiva f'Gilenya, il-fingolimod, twaqqaf liċ-ċelloli T (tip ta' ċellola tad-demm bajda li hija involuta fis-sistema immunitarja) li jmorru millgħoqiedi limfatiċi lejn il-moħħ u s-sinsla tad-dahar, u b'hekk tillimita l-ħsara li jikkawżaw fl-isklerożi multipla.
English: It must also ensure that all doctors who prescribe Gilenya receive an information pack containing important safety information, including a checklist of the risks with Gilenya and the situations where its use is not recommended.
Maltese: Din għandha tiżgura wkoll li t-tobba kollha li jippreskrivu Gilenya jirċievu pakkett ta' tagħrif li jkun fih informazzjoni importanti dwar is-sigurtà, inkluża lista tar-riskji b'Gilenya u s-sitwazzjonijiet fejn mhuwiex irrakkomandat l-użu tiegħu.
English: What measures are being taken to ensure the safe and effective use of Gilenya?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Gilenya?
English: Because Gilenya decreases the heart rate and can affect the heart's electrical activity and rhythm, the patient's blood pressure and heart activity is checked before starting treatment and during treatment, and also if Gilenya treatment is restarted after an interruption.
Maltese: Minħabba li Gilenya jnaqqas ir-rata tat-taħbit ta' qalb u jista' jaffettwa l-attività elettrika u r-ritmu talqalb, il-pressjoni tad-demm u l-attività tal-qalb tal-pazjent jiġu eżaminati qabel tinbeda l-kura u matul il-kura, u anke jekk il-kura b'Gilenya terġa' tinbeda wara interruzzjoni.
English: Gilenya must not be used in patients at risk of infections due to a weakened immune system, patients with a severe infection or a long-term active infection such as hepatitis, and patients with cancer or severe liver problems.
Maltese: Gilenya ma għandux jintuża f'pazjenti li qegħdin f'riskju ta' infezzjonijiet minħabba sistema immunitarja dgħajfa, pazjenti b'infezzjoni severa jew infezzjoni attiva fuq perjodu twil bħall-epatite, u pazjenti b'kanċer jew bi problemi severi fil-fwied.