FrancophonIA/ELRC3.0 huggingface dataset:
English: Unless continued ACE inhibitor therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Maltese: Din il-bidla fit-test hija biex tassigura li ma tissuġġerixxix abort artifiċjali immedjat, li mhuwiex iġġustifikat mill-esperjenzi kliniċi miġburin s'issa.
English: BEFORE YOU TAKE TRITACE
Maltese: TRITACE jista'
English: When pregnancy is diagnosed, treatment with ACE inhibitors/ AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
Maltese: Jekk tiġi dijanjostikata t-tqala, il-kura bl-inibituri ACE/AIIRAs għandu jitwaqqaf minnufih, u jekk ikun hemm bżonn, tinbeda kura alternattiva (ara sezzjonijiet 4.3 u 4.6).
English: Vasopressor sympathomimetics and other substances (e.g. isoproterenol, dobutamine, dopamine, epinephrine) that may reduce the antihypertensive effect of TRITACE: Blood pressure monitoring is recommended.
Maltese: Simpatomimetiċi vasopressor u sustanzi oħra (eż. isoprotenerol, dobutamine, dopamine, epinephrine) li jistgħu jnaqqsu l-effett antiipertensiv ta' TRITACE:
English: Secondary prevention after acute myocardial infarction In all countries where the post myocardial infarction indication has been approved the initial recommended dose is 2.5 mg twice daily.
Maltese: Prevenzjoni sekondarja wara infart mijokardijaku akut Fil-pajjiżi kollha fejn l-indikazzjoni wara infart mijokardijaku ġiet approvata, id-doża inizjali rakkomandata hija 2.5 mg darbtejn kuljum.
English: • The usual starting dose is 1.25 mg or 2.5 mg once daily.
Maltese: • Normalment id-doża tal-bidu hija 1.25 mg jew 2.5 mg darba kuljum.
English: The CHMP agreed that in patients with diabetes and microalbuminuria the recommended initial dose is 1.25 mg of Tritace once daily.
Maltese: Is-CHMP qabel li f'pazjenti bid-dijabete u b'mikroalbuminurja, id-doża tal-bidu rakkomandata hija 1.25 mg Tritace darba kuljum.
English: Extensive mutagenicity testing using several test systems has yielded no indication that ramipril possesses mutagenic or genotoxic properties.
Maltese: Testijiet estensivi ta' mutaġeniċità bl-użu ta' bosta sistemi ta' testijiet ma ta ebda indikazzjoni li ramipril għandu karatteristiċi mutaġeniċi jew genetossiċi.
English: In summary, pregnancy and lactation should be amended in line with PhVWP recommendations on ACE-I The following should be added to the contraindication:
Maltese: Fil-qosor, is-sezzjoni tqala u treddigħ għandha tiġi emendata f'konformità mar-rakkomandazzjonijiet PhVWP dwar ACE-inibituri Dan li ġej għandu jiżdied mal-kontraindikazzjoni:
English: Latvia: Cardace 2.5 mg tabletes, Cardace 5 mg tabletes, Cardace 10 mg tabletes
Maltese: Cardace 2.5 mg tabletes, Cardace 5 mg tabletes, Cardace 10 mg tabletes
English: PHARMACOKINETIC PROPERTIES
Maltese: GĦAMLA FARMAĊEWTIKA
English: Myocardial ischaemia including angina pectoris or myocardial infarction,
Maltese: Sustanzi antidijabetiċi inkluża l-insulina:
English: Depressed mood, anxiety, nervousness, restlessness, sleep disorder including somnolence
Maltese: Tħossok imdejjaq, ansjetà, nervożità, irrekwitezza disturbi fl-irqad inkluż ħedla ta' ngħas
English: Gastrointestinal inflammation, digestive disturbances, abdominal discomfort, dyspepsia, diarrhoea, nausea, vomiting
Maltese: Glikosurja, alkalożi metabolika, ipoklorimja, ipomagnesimja, iperkalċimja, deidratazzjoni minħabba hydrochlorothiazide
English: The ramipril treatment was started 3 to 10 days after the acute myocardial infarction.
Maltese: Il-kura b'ramipril nbeda 3 sa 10 ijiem wara l-infart mijokardijaku akut.
English: Patients with increased risk of cardiovascular disease following either atherothrombotic cardiovascular disease (history of coronary heart disease, stroke or peripheral vascular disease) or diabetes mellitus with at least one additional risk factor (documented microalbuminuria, hypertension, elevated total cholesterol level, low high-density lipoprotein cholesterol level or cigarette smoking) were included in the study.
Maltese: Ġew inklużi fl-istudju, pazjenti b'żieda fir-riskju ta' mard kardjovaskulari wara jew mard kardjovaskulari aterotrombotiku (passat mediku ta' mard koronarju talqalb, attakk ta' puplesija, jew mard vaskulari periferiku) jew dijabete mellitus b'għallinqas fattur ieħor ta' riskju (evidenza ta' mikroalbuminurja, ipertensjoni, livell għoli tat-total ta' kolesterol, livell baxx tal-lipoproteina tal-kolesterol b'densita għolja jew tipjip).
English: • Fever
Maltese: • Fawra
English: Slovenia: Tritace 1.25 mg tablete, Tritace 2.5 mg tablete, Tritace 5 mg tablete, Tritace 10 mg tablete
Maltese: Tritace 1.25 mg tablete, Tritace 2.5 mg tablete, Tritace 5 mg tablete, Tritace 10 mg tablete
English: Patients at risk for development of hyperkalaemia include those with renal insufficiency, age (> 70 years), uncontrolled diabetes mellitus, or those using potassium salts, potassium retaining diuretics and other plasma potassium increasing active substances, or conditions such as dehydration, acute cardiac decompensation, metabolic acidosis.
Maltese: Pazjenti f'riskju li jiżviluppaw l-iperkalimja jinkludi dawk b'insuffiċjenza renali, età (> 70 sena), dijabete mellitus li mhix ikkontrollata jew dawk li qed jieħdu salts tal-potassju, dijuretiċi li jżommu l-potassju u sustanzi attivi oħra li jżidu l-livell ta' potassju fil-plażma jew kundizzjonijiet bħal deidratazzjoni, dekompensazzjoni kardijaka akuta, aċidożi metabolika.
English: After multiple once-daily doses of ramipril, the effective half-life of ramiprilat concentrations was 1317 hours for the 5-10 mg doses and longer for the lower 1.25-2.5 mg doses.
Maltese: Wara dożi multipli ta' ramipril darba kuljum, il-half-life effettiv tal-konċentrazzjonijiet ta' ramiprilat kien ta' 13-17-il siegħa għad-dożi ta' 5-10 mg u itwal għad-dożi iżgħar ta' 1.25-2.5 mg.
English: UNDESIRABLE EFFECTS
Maltese: EFFETTI
English: Bulgaria: Tritace 2.5 mg таблетки, Tritace 5 mg таблетки, Tritace 10 mg таблетки
Maltese: Il-Polonja: Tritace 2.5 mg tabletki, Tritace 5 mg tabletki, Tritace 10 mg tabletki
English: In addition to conventional therapy with diuretics and optional cardiac glycosides, ramipril has been shown to be effective in patients with functional classes II-IV of the New-York Heart Association.
Maltese: Minbarra t-terapija konvenzjonali bid-dijuretiċi u jekk tkun trid il-glikosidi kardijaċi, ġie muri li ramipril hu effettiv f'pazjenti b'kategoriji funzjonali
English: ACE inhibitor/ Angiotensin II Receptor Antagonist (AIIRA) therapy exposure during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
Maltese: Espożizzjoni għat-terapija blinibituri ACE/ Antagonisti għar-Riċettur ta' AnġjotensinII waqt it-tieni u t-tielet trimestri ta' tqala hu magħruf li jikkawża fetotossiċità umana (tnaqqis fil-funzjoni renali, nuqqas fl-ammont ta' fluwidu amnjotiku, dewmien fl-ossifikazzjoni tal-kranju) u tossiċità tat-tarbija tat-twelid (insuffiċjenza renali, ipotensjoni, iperkalimja).
English: The MAH calls on a high level of evidence for ACE-Is administered in the first 24 hours following acute myocardial infarction (MI) in international recommendations, to justify initiating therapy with 24 hours of MI at the lowest dose of 1.25 mg daily (that used as first dose in the heart failure indication), provided that stable haemodynamic conditions are met and the regulatory precedent with lisinopril wording.
Maltese: Biex jiġġustifika l-bidu tatterapija f'24 siegħa mill-infart mijokardiku bid-doża minima ta' 1.25 mg/kuljum (l-istess użata bħala lewwel doża għall-indikazzjoni tal-insuffiċjenza kardijaka), diment li jkun hemm il-kundizzjonijiet emodinamiċi stabbli u f'kunsiderazzjoni tar-regolament preċedenti dwar it-test dwar lisinopril, ilMAH jitlob livell għoli ta' provi favur l-ACE-inibituri mogħtija fl-ewwel 24 siegħa wara l-infart mijokardiku (MI) akut fir-rakkomandazzjonijiet internazzjonali.
English: Ramiwin 1.25 mg tabletta, Ramiwin 2.5 mg tabletta, Ramiwin 5 mg tabletta, Ramiwin 10 mg tabletta
Maltese: 2.5 mg tabletta, Ramiwin 5 mg tabletta, Ramiwin 10 mg tabletta
English: Czech Republic:
Maltese: Ir-Repubblika Ċeka:
English: • Swollen mouth
Maltese: • Tħossok sturdut.
English: Romania
Maltese: IR-RUMANIJA
English: ROMANIA
Maltese: Ir-Rumanija
English: Cough
Maltese: Qawwa
English: Denmark:
Maltese: Id-Danimarka:
English: • Chest pain
Maltese: • Tħossok debboli
English: The current indication of ramipril in hypertension differs among the EU countries.
Maltese: L-indikazzjoni attwali ta' ramipril fl-ipertensjoni tvarja fost il-pajjiżi tal-UE.
English: Ramipril must not be used in patients in patients with hypotensive or haemodynamically unstable states
Maltese: Ma kienx hemm indeboliment fil-fertilità kemm fil-firien irġiel u kemm fil-firien nisa.
English: The CHMP agreed the following: “The dose should be individualised according to the patient profile (see section 4.4) and blood pressure control.
Maltese: Is-CHMP qabel fuq dan il ġej: “Id-doża għandha tkun individwalizzata skont il-profil tal-pazjent (ara sezzjoni 4.4) u l-kontroll talpressjoni tad-demm.
English: Based on urinary recovery, the extent of absorption is at least 56 % and is not significantly influenced by the presence of food in the gastrointestinal tract.
Maltese: Skont l-ammont irkuprat millawrina, it-total li jiġi assorbit hu mill-inqas 56 % u mhuwiex affettwat b'mod sinifikanti mill-presenza tal-ikel fil-passaġġ gastrointestinali.
English: Gynaecomastia
Maltese: IPPREŻENTATI
English: Suggested measures include primary detoxification (gastric lavage, administration of adsorbents) and measures to restore haemodynamic stability, including, administration of alpha 1 adrenergic agonists or angiotensin II (angiotensinamide) administration.
Maltese: Miżuri rakkomandati jinkludu detossifikazzjoni primarja (lavaġ gastriku, l-għoti ta' assorbenti) u miżuri biex jerġgħu jġibu lura l-istabbilità emodinamika li jinkludu l-għoti ta' agonisti adrenerġiċi alfa 1 jew lgħoti ta' anġjotensin II (anġjotensinamid).
English: B-1050 Bruxelles
Maltese: A-1037 Wien
English: Rash in particular maculo-papular
Maltese: Raxx b'mod partikulari makulopapulari
English: Lithium salts: Excretion of lithium may be reduced by ACE inhibitors and therefore lithium toxicity may be increased.
Maltese: Lithium salts : It-tneħħija mill-ġisem ta' lithium tista' titnaqqas minħabba l-inibituri ACE u għalhekk tista' tiżdied it-tossiċità mil-lithium.
English: There are contraindications present in one or several local SPCs.
Maltese: Hemm kontraindikazzjonijiet preżenti f'waħda jew bosta SPCs lokali.
English: Tritace and associated names may be used in monotherapy or in combination with other classes of antihypertensive medicinal products”.
Maltese: Tritace u ismijiet assoċjati jista' jintuża f'monoterapija jew f'kombinazzjoni ma' klassijiet oħra ta' prodotti mediċinali kontra l-ipertensjoni”.
English: SANOFI-AVENTIS D.O.O.
Maltese: SANOFI-AVENTIS D.O.O. Dunajska cesta 119
English: o Elderly patients See section 4.2.
Maltese: ○ Pazjenti Anzjani Ara sezzjoni 4.2
English: Hepatic enzymes and/or bilirubin conjugated increased,
Maltese: Żieda fl-enzimi epatiċi u/jew żieda fil-bilirubin konġjugat
English: Exfoliative dermatitis, urticaria, onycholysis,
Maltese: Infjammazzjoni gastro-intestinali, disturbi diġestivi,
English: Pyrexia
Maltese: Ċipru
English: • During the last 6 months of pregnancy (see section below on “Pregnancy and breast-feeding”)
Maltese: • Waqt l-aħħar 6 xhur ta' tqala (ara is-sezzjoni hawn taħt "Tqala u treddigħ")
English: Sufficient experience is still lacking in the treatment of patients with severe (NYHA IV) heart failure immediately after myocardial infarction.
Maltese: Għad m'hemmx biżżejjed esperjenza fil-kura ta' pazjenti b'insuffiċjenza tal-qalb gravi (NYHA IV) eżattament wara infart mijokardijaku.
English: • Feeling weak
Maltese: Pazjenti b'indeboliment renali
English: Contra-indicated combinations
Maltese: 4.3 Kontra-indikazzjonijiet
English: Hyperkalaemia
Maltese: L-Awstrija
English: • The usual starting dose is 1.25 mg once daily.
Maltese: • Normalment id-doża tal-bidu hija 1.25 mg darba kuljum.
English: • Feeling dizzy.
Maltese: • Sensazzjoni ta' ħruq
English: • If you have heart, liver or kidney problems
Maltese: • Jekk għandek problemi tal-qalb, fwied jew kliewi
English: Felisecto Plus (selamectin / sarolaner)
Maltese: Felisecto Plus (selamektina / sarolaner)
English: Further information on Felisecto Plus can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/felisecto-plus.
Maltese: ema.europa.eu/medicines/veterinary/EPAR/felisecto-plus.
English: Other information about Felisecto Plus
Maltese: Informazzjoni oħra dwar Felisecto Plus
English: • to treat adult roundworms and adult hookworms in the gut
Maltese: • biex tikkura ħniex tondi adulti u hookworms intestinali adulti
English: Felisecto Plus contains selamectin and sarolaner, which are antiparasitic medicines.
Maltese: Felisecto Plus fih is-selamektina u s-sarolaner, li huma mediċini antiparassitiċi.
English: Felisecto Plus kills fleas and some ticks within 24 hours and it continues to work for 5 weeks against fleas and 4 to 5 weeks against ticks (depending on the type).
Maltese: Felisecto Plus joqtol il-briegħed u xi qurdien f'24 siegħa u dan ikompli jaħdem għal 5 ġimgħat kontra lbriegħed u għal 4 sa 5 ġimgħat kontra l-qurdien (skont it-tip).
English: Felisecto Plus was as effective as the other medicine and reduced tick counts by more than 90%.
Maltese: Felisecto Plus kien effettiv daqs il-mediċina l-oħra u naqqas l-għadd ta' qurdien b'aktar minn 90 %.
English: Two laboratory studies with cats artificially infested with ear mites showed Felisecto Plus to reduce ear mites by more than 90% 30 days after a single treatment.
Maltese: Żewġ studji fil-laboratorju bi qtates li ġew infestati b'mod artifiċjali bil-mites tal-widnejn urew li Felisecto Plus inaqqas il-mites tal-widnejn b'aktar minn 90 % 30 jum wara kura waħda.
English: Selamectin is effective against fleas, ear mites, biting lice, heartworm larvae, roundworms and hookworms.
Maltese: Isselamektina hi effettiva kontra l-briegħed, il-mites tal-widnejn, il-qamel li jigdem, il-larva talheartworm, il-ħniex tondi u l-hookworms.
English: The company that makes Stronghold Plus has agreed that its scientific data can be used for Felisecto Plus (‘informed consent').
Maltese: Ilkumpanija li tipproduċi Stronghold Plus qablet li d-data xjentifika tagħha tista' tintuża għal Felisecto Plus (“kunsens infurmat”).
English: Sarolaner blocks the normal movement of charged chloride particles in and out of nerve cells, especially those associated with gamma-aminobutyric acid (GABA) and glutamate, two substances that convey messages between nerves (neurotransmitters).
Maltese: Is-sarolaner timblokka l-moviment normali tal-partikoli ċċarġjati tal-klorur ġewwa u barra ċ-ċelloli tannervituri, speċjalment dawk assoċjati ma' aċidu gamma-aminobutirriku (GABA, gamma-aminobutyric acid) u ma' glutamat, żewġ sustanzi li jgħaddu l-messaġġi bejn in-nervituri (newrotrażmettituri).
English: Two laboratory studies were conducted in cats with intestinal worms which showed Felisecto Plus to have more than 94% effectiveness.
Maltese: Saru żewġ studji fil-laboratorji fi qtates b'dud intestinali li wrew li Felisecto Plus għandu effikaċja ta' aktar minn 94 %.
English: Felisecto Plus contains two active substances, selamectin and sarolaner.
Maltese: Felisecto Plus fih żewġ sustanzi attivi, selamektina u sarolaner.
English: What are the risks associated with Felisecto Plus?
Maltese: X'inhuma r-riskji assoċjati ma' Felisecto Plus ?
English: Selamectin activates special proteins called ‘chloride channels' on the surface of nerve and muscle cells of the parasite, allowing charged chloride particles to enter nerve cells and disrupting their normal electrical activity.
Maltese: Is-selamektina tattiva proteini speċjali msejħa “kanali tal-klorur” fuq il-wiċċ taċ-ċelloli tan-nervituri u tal-muskoli tal-parassita u b'hekk tippermetti l-partikoli ċċarġjati tal-klorur jidħlu fiċ-ċelloli tan-nervituri u jfixklu l-attività elettrika normali tagħhom.
English: This authorisation was based on the authorisation granted to Stronghold Plus in 2017 (‘informed consent').
Maltese: Din l-awtorizzazzjoni kienet ibbażata fuq l-awtorizzazzjoni mogħtija lil Stronghold Plus fl-2017 (“kunsens infurmat”).
English: A laboratory study with cats artificially infected with heartworm showed Felisecto Plus to be effective for the prevention of heartworm disease.
Maltese: Studju fil-laboratju bi qtates li kienu infestati b'mod artifiċjali bil-heartworm urew li Felisecto Plus hu effettiv għall-prevenzjoni tal-marda tal-heartworm.
English: The most common side effects with Felisecto Plus (which may affect up to 1 in 100 cats) are mild to moderate alopecia (hair loss) at the application site, erythema (reddening of the skin) and drooling.
Maltese: L-effetti sekondarji l-aktar komuni b'Felisecto Plus (li jistgħu jaffettwaw sa qattus 1 minn kull 100) huma alopeċja ħafifa sa moderata (telf tax-xagħar) fis-sit tal-applikazzjoni, eritema (ħmura tal-ġilda) u tlegħib ta' bżiq.
English: • to treat tick infestations
Maltese: • biex tikkura infestazzjonijiet ta' qurdien
English: • to treat ear mites
Maltese: • biex tikkura mites tal-widnejn
English: A laboratory study with cats infested with biting lice showed selamectin to eliminate biting lice for 42 days after treatment compared to placebo treated cats.
Maltese: Studju fil-laboratorju bi qtates infestati b'qamel li jigdem wera li s-selamektina telimina l-qamel li jigdem għal 42 jum wara l-kura meta mqabbel ma' qtates ikkurati bil-plaċebo.
English: The effectiveness of Felisecto Plus was investigated in a field study in cats naturally infested with fleas.
Maltese: L-effikaċja ta' Felisecto Plus ġiet investigata fi studju fuq il-post fi qtates li kienu infestati b'mod naturali bil-briegħed.
English: Felisecto Plus is a medicine used to treat mixed infestations with both ticks and other parasites that may be found on the skin or fur of cats, such as fleas, ear mites and lice and/or worms that can enter and infect the body.
Maltese: Felisecto Plus huwa mediċina li tintuża għall-kura ta' infestazzjonijiet imħallta kemm bil-qurdien kif ukoll b'parassiti oħra li jistgħu jinstabu fuq il-ġilda jew il-pil tal-qtates, bħall-briegħed, mites talwidnejn u qamel u/jew dud li jista' jidħol fil-ġisem u jinfettah.
English: • to prevent heartworm disease
Maltese: • biex tipprevjeni l-marda tal-heartworm
English: How is Felisecto Plus used?
Maltese: Kif jintuża Felisecto Plus?
English: How does Felisecto Plus work?
Maltese: Kif jaħdem Felisecto Plus?
English: Felisecto Plus is available as a spot-on solution in three different strengths and can only be obtained with a prescription.
Maltese: Felisecto Plus jiġi bħala soluzzjoni spot-on fi tliet qawwiet differenti u jista' jinkiseb biss b'riċetta ta' tabib.
English: It can also be used as part of a treatment for flea allergy dermatitis (an allergic reaction to flea bites)
Maltese: Din tista' tintuża wkoll bħala parti minn kura għal dermatite allerġika għall-briegħed (reazzjoni allerġika għal gdim tal-briegħed)
English: This results in uncontrolled activity of the nervous system and the paralysis and death of the parasites.
Maltese: Dan iwassal għal attività mhux ikkontrollata tas-sistema nervuża u l-paraliżi u l-mewt tal-parassiti.
English: Sarolaner is effective against ticks and fleas.
Maltese: Issarolaner hi effettiva kontra l-qurdien u l-briegħed.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Felisecto Plus, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Maltese: Fis-sommarju tal-karatteristiċi tal-prodott u l-fuljett ta' tagħrif ġiet inkluża informazzjoni rigward issigurtà ta' Felisecto Plus, inkluż il-prekawzjonijiet xierqa li għandhom ikunu segwiti mill-professjonisti fil-qasam tal-kura tas-saħħa u mis-sidien tal-annimali jew dawk li jieħdu ħsiebhom.
English: EMA/639971/2015 EMEA/H/C/002715
Maltese: EMA/639971/2015 EMA/H/C/002715
English: Ionsys fentanyl
Maltese: Ionsys fentanil
English: The full EPAR and risk management plan summary for Ionsys 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 proportion of patients who stopped treatment because their pain was not controlled was lower in patients treated with Ionsys (and ranged between 8% and 27%) than in those treated with placebo (where it ranged between 40 and 57%).
Maltese: Ilproporzjon ta' pazjenti li waqqfu l-kura peress li l-uġigħ tagħhom ma kienx ikkontrollat kien iktar baxx f'pazjenti kkurati b'Ionsys (u varja bejn 8 % u 27 %) minn f'dawk ikkurati bi plaċebo (fejn varja bejn 40 % u 57 %).
English: This is a summary of the European public assessment report (EPAR) for Ionsys.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Ionsys.
English: Why is Ionsys approved?
Maltese: Għal xiex ġie approvat Ionsys?
English: It contains the active substance fentanyl.
Maltese: Fih is-sustanza attiva fentanil.
English: These are usually mild to moderate in severity.
Maltese: Dawn normalment ikunu ħfief sa moderati bħala severità.
English: The safety profile is acceptable and is similar to morphine given by injection into a vein.
Maltese: Il-profil tas-sigurtà huwa aċċettabbli u huwa simili għal dak talmorfina mogħtija b'injezzjoni ġol-vina.
English: Ionsys can be used up to six times in one hour, but for no more than 80 doses within a 24-hour period.
Maltese: Ionsys jista' jintuża sa sitt darbiet f'siegħa, iżda mhux għal iktar minn 80 doża fi żmien perjodu ta' 24 siegħa.
English: In three of the studies, Ionsys was compared with placebo (a dummy system).
Maltese: Fi tliet studji minnhom, Ionsys tqabbel ma' plaċebo (sistema finta).
English: Other information about Ionsys
Maltese: Informazzjoni oħra dwar Ionsys
English: Ionsys is a transdermal system used to control moderate to severe pain after an operation in adults who are in hospital.
Maltese: IONSYS hija sistema li tgħaddi l-mediċina minn ġol-ġilda li tintuża biex tikkontrolla wġigħ moderat sa sever wara operazzjoni fl-adulti li jkunu rikoverati l-isptar.
English: Ionsys transdermal system delivers the active substance, fentanyl, through the skin.
Maltese: Ionsys sistema li tgħaddi l-mediċina mill-ġilda tagħti s-sustanza attiva, fetanil, mill-ġilda.
English: Ionsys must not be used in patients with severe respiratory depression (breathing problems) or with a rare condition called cystic fibrosis.
Maltese: Ionsys ma għandux jintuża f'pazjenti b'dipressjoni respiratorja severa (problemi fit-teħid tan-nifs) jew b'kundizzjoni rari msejħa fibrożi ċistika.
English: What are the risks associated with Ionsys?
Maltese: X'inhuma r-riskji assoċjati ma' Ionsys?
English: Ionsys has been shown to be effective at controlling pain after an operation in seven main studies involving a total of around 3,300 patients.
Maltese: Ionsys intwera li huwa effettiv biex jikkontrolla l-uġigħ wara tħaddim f'seba' studji ewlenin li jinvolvu total ta' madwar 3,300 pazjent.
English: The other four studies compared Ionsys with morphine given by injection into a vein, and looked at the number of patients who judged their pain relief as ‘good' or ‘excellent'.
Maltese: L-erba' studji l-oħra qabblu Ionsys ma' morfina mogħtija b'injezzjoni ġol-vina, u eżaminaw in-numru ta' pazjenti li qiesu s-serħan mill-uġigħ tagħhom bħala "tajjeb" jew "eċċellenti".
English: When in pain, the patient uses a button on the Ionsys system to start the delivery of a dose of fentanyl (40 micrograms).
Maltese: Meta jkollu l-uġigħ, il-pazjent juża buttuna fuq is-sistema Ionsys biex jibda l-għoti ta' doża ta' fentanil (40 mikrogramma).
English: For the full list of all side effects reported with Ionsys, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Ionsys, ara lfuljett ta' tagħrif.