FrancophonIA/ELRC3.0 huggingface dataset:
English: Supplemental vitamin D reduces these risks and their consequences.
Maltese: Vitamina D supplimentari tnaqqas dawn ir-riskji u l-konsegwenzi tagħhom.
English: Alendronate can cause local irritation of the upper gastrointestinal mucosa.
Maltese: Reazzjonijiet avversi gastrointestinali tan-naħa ta' fuq Alendronate jista' jikkaġuna irritazzjoni lokali tal-mukoża gastrointestinali tan-naħa ta' fuq.
English: • you are taking angiogenesis inhibitors (such as bevacizumab, or thalidomide) which are used in the treatment of cancer,
Maltese: • qed tieħu inibituri tal-anġjoġenesi (bħal bevacizumab, jew thalidomide) li jintużaw għall-kura tal-kanċer,
English: The principal action of 1,25-dihydroxyvitamin D3 is to increase intestinal absorption of both calcium and phosphate as well as regulate serum calcium, renal calcium and phosphate excretion, bone formation and bone resorption.
Maltese: L-azzjoni prinċipali ta' 1,25-dihydroxyvitamin D3 hija li żżid l-assorbiment intestinali kemm tal-kalċju u l-fosfat kif ukoll li tirregola l-kalċju fis-serum, ilkalċju renali u l-eliminazzjoni tal-fosfat, il-formazzjoni tal-għadam u l-assorbiment mill-ġdid talgħadam.
English: • if you are allergic to alendronic acid, colecalciferol or any of the other ingredients of this medicine (listed in section 6),
Maltese: • jekk inti allerġiku għal alendronic acid, colecalciferol jew għal xi sustanza oħra ta' din il mediċina (elenkati fis-sezzjoni 6),
English: Read the Package Leaflet before use.
Maltese: Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu fis-suq.
English: Common headache, dizziness Uncommon dysgeusia
Maltese: Komuni astenja†, edima periferali†
English: • potency of the bisphosphonate (highest for zoledronic acid), route of administration (see above)
Maltese: • il-qawwa tal-bisphosphonate (l-ogħla riskju għal zoledronic acid), minn fejn jingħata (ara hawn fuq) u d-doża kumulattiva
English: VANTAVO is not recommended for patients with renal impairment where creatinine clearance is less than 35 ml/min, due to lack of experience.
Maltese: VANTAVO m'huwiex irrakkomandat għal pazjenti b'indeboliment renali fejn it-tneħħija talkreatinina hija anqas minn 35 ml/min, minħabba nuqqas ta' esperjenza.
English: VANTAVO 70 mg/5,600 IU tablets are available as modified rectangle-shaped, white to off-white tablets marked with an outline of a bone image on one side and ‘270' on the other.
Maltese: VANTAVO 70 mg/5600 IU pilloli jiġu bħala pilloli modifikati f'għamla ta' rettangolu, ta' lewn bajdani jew bojod jagħtu fil-griż immarkati b' kontorn ta' immaġni ta' għadma fuq naħa u '270' fuq in-naħa loħra.
English: Because there is a potential for worsening of the underlying disease, caution should be used when alendronate is given to patients with active upper gastrointestinal problems, such as dysphagia, oesophageal disease, gastritis, duodenitis, ulcers, or with a recent history (within the previous year) of major gastrointestinal disease such as peptic ulcer, or active gastrointestinal bleeding, or surgery of the upper gastrointestinal tract other than pyloroplasty (see section 4.3).
Maltese: Minħabba li hemm il-potenzjal għal deterjorament tal-marda prinċipali, għandha tintuża l-kawtela meta alendronate jingħata lil pazjenti bi problemi gastrointestinali attivi tan-naħa ta' fuq, bħal disfaġja, mard tal-esofaġu, gastrite, duwodenite, ulċeri, jew bi storja riċenti (fi żmien l-aħħar sena) ta' mard gastrointestinali maġġur bħal ulċeri peptiċi, jew emorraġiji gastrointestinali attivi, jew kirurġija fuq ilpassaġġ gastrointestinali tan-naħa ta' fuq ħlief għal piloroplasti (ara sezzjoni 4.3).
English: Therefore, patients must wait at least 30 minutes after taking alendronate before taking any other oral medicinal product (see sections 4.2 and 5.2).
Maltese: Għalhekk, il-pazjenti għandhom jistennew tal-anqas 30 minuta wara li jieħdu alendronate qabel ma jieħdu xi prodott medicinali orali ieħor (ara sezzjoni 4.2 u 5.2).
English: Vitamin D3 is converted to 25-hydroxyvitamin D3 in the liver, and stored until needed.
Maltese: Il-vitamin D3 hija mibdula f'25-hydroxyvitamin D3 fil-fwied, u maħżuna sakemm tkun meħtieġa.
English: • headache; dizziness,
Maltese: • nefħa fil-ġogi,
English: VANTAVO 70 mg/5,600 IU tablets Aluminium/aluminium blisters, in cartons containing 2, 4 or 12 tablets.
Maltese: VANTAVO 70 mg/56000 IU pilloli jiġu f'pakketti li fihom 2, 4 jew 12-il pillola.
English: Osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection (including osteomyelitis), has been reported in patients with cancer who are receiving treatment regimens including primarily intravenously administered bisphosphonates.
Maltese: Osteonekrożi tax-xedaq, ġeneralment assoċjata ma' qlugħ tas-snien u/jew infezzjonijiet lokali (inklużi osteomajlite), ġiet irrapportata f'pazjenti bil-kanċer li qed jieħdu reġimen ta' trattamenti li jinkludu bisphosphonates mogħtija prinċipalment minn ġol-vina.
English: Atypical subtrochanteric and diaphyseal femoral fractures have been reported with bisphosphonate therapy, primarily in patients receiving long-term treatment for osteoporosis.
Maltese: Subset minnhom kellhom rikorenza tas-sintomi meta ġew sfidati mill-ġdid bl-istess prodott mediċinali jew bisphosphonate ieħor.
English: In the absence of adequate sunlight exposure, vitamin D3 is an essential dietary nutrient.
Maltese: Fin-nuqqas ta' esponiment adekwat għad-dawl tax-xemx, il-vitamina D3 hija nutrijent essenzjali tad-dieta.
English: Patients should receive supplemental calcium if intake from diet is inadequate (see section 4.4).
Maltese: Il-pazjenti għandhom jingħataw kalċju supplimentali jekk it-teħid tiegħu mad-dieta ma jkunx adegwat (ara sezzjoni 4.4).
English: In healthy adult subjects (males and females), following administration of VANTAVO 70 mg/2,800 IU tablets after an overnight fast and two hours before a meal, the mean area under the serum-concentration-time curve (AUC0-120 hrs) for vitamin D3 (unadjusted for endogenous vitamin D3 levels) was 296.4 ng•hr/ml.
Maltese: Wara l-għoti ta' pilloli ta' 70 mg/2800 IU VANTAVO f'suġġetti adulti b'saħħithom (irġiel u nisa) wara sawma tul il-lejl u sagħtejn qabel ikla, l-erja medja taħt il-kurva tal-konċentrazzjoni tas-serum mal-ħin (AUC0-120 hrs) għal vitamina D3 (mhux aġġustata għal-livelli ta' vitamina D3 endoġena) kienet ta' 296.4 ng•hr/ml.
English: Concomitant administration of alendronate with coffee or orange juice reduced bioavailability by approximately 60 %.
Maltese: Għoti konkomitanti ta' alendronate mal-kafè jew meraq tal-larinġ naqqas ilbijodisponibiltà b'bejn wieħed u ieħor 60 %.
English: VANTAVO is indicated for the treatment of postmenopausal osteoporosis in women at risk of vitamin D insufficiency.
Maltese: Antikonvulsanti, cimetidine u thiazides jistgħu jżiedu lkataboliżmu ta' vitamina D.
English: Hypocalcaemia, hypophosphataemia and upper gastrointestinal adverse reactions, such as upset stomach, heartburn, oesophagitis, gastritis, or ulcer, may result from oral overdose.
Maltese: Ipokalċemija, ipofosfatemija u reazzjonijiet avversi gastrointestinali tan-naħa ta' fuq, bħall-istonku mħawwad, qrusa fl-istonku, esofaġite, gastrite, jew ulċeri, jistgħu jirriżultaw minn doża orali eċċessiva.
English: While on treatment, these patients should avoid invasive dental procedures if possible.
Maltese: Waqt it-trattament, dawn il-pazjenti għandhom jevitaw proċeduri dentali invażivi jekk huwa possibbli.
English: The active substances are alendronic acid and colecalciferol (vitamin D3).
Maltese: Is-sustanzi attivi huma alendronic acid u colecalciferol (vitamin D3). Kull VANTAVO 70 mg/2800 IU
English: Patients received the lower strength (70 mg/2800 IU) of VANTAVO (n=350) or FOSAMAX (alendronate) 70 mg (n=332) once a week; additional vitamin D supplements were prohibited.
Maltese: (alendronate) 70 mg (n=332) darba fil-ġimgħa; supplimenti addizzjonali ta' vitamina D kienu projbiti.
English: The percentage of patients with vitamin D insufficiency was 5.4 % in the Vitamin D3 2,800 group vs. 3.2 % in the Vitamin D3 5,600 group through the 24-week extension.
Maltese: 3.2 % fil-grupp talVitamina D3 5600 matul l-estensjoni ta' 24 ġimgħa.
English: Oesophageal reactions (sometimes severe and requiring hospitalisation), such as oesophagitis, oesophageal ulcers and oesophageal erosions, rarely followed by oesophageal stricture, have been reported in patients receiving alendronate.
Maltese: Reazzjonijiet esofaġiċi (xi kultant serji u li jeħtieġu d-dħul fl-isptar), bħal esofaġite, ulċeri esofaġiċi u erożjonijiet esofaġiċi, rarament segwiti b'tidjiq esofaġiku, ġew irrapportati f'pazjenti li qed jieħdu alendronate.
English: Vitamin D3 is rapidly distributed mostly to the liver where it undergoes metabolism to 25-hydroxyvitamin D3, the major storage form.
Maltese: Il-vitamina D3 hija distribwita malajr l-aktar fil-fwied fejn tgħaddi minn metaboliżmu għal 25-hydroxyvitamin D3, ilforma ta' ħażna prinċipali.
English: Relative to an intravenous reference dose, the oral mean bioavailability of alendronate in women was 0.64 % for doses ranging from 5 to 70 mg when administered after an overnight fast and two hours before a standardised breakfast.
Maltese: B'mod relattiv ma' doża ta' referenza mogħtija ġol-vina, il-bijodisponibiltà orali medja ta' alendronate fin-nisa kienet 0.64 % għal dożi li jvarjaw minn 5 sa 70 mg meta mogħtija wara sawma ta' matul il-lejl u sagħtejn qabel kolazzjon standardizzat.
English: • abdominal pain; uncomfortable feeling in the stomach or belching after eating; constipation; full or bloated feeling in the stomach; diarrhoea; flatulence,
Maltese: • uġigħ addominali; sensazzjoni ta' skonfort fl-istonku jew tifwiq wara l-ikel; stitikezza;
English: The full EPAR for Abilify Maintena 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: This summary was last updated in 02-2015.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi 02-2015.
English: Abilify Maintena aripiprazole
Maltese: Abilify Maintena aripiprażol
English: Abilify Maintena is available as a powder (300 mg and 400 mg) and solvent to be made into a prolonged-release suspension for injection.
Maltese: Abilify Maintena jiġi bħala trab (300 mg u 400 mg) u solvent li għandu jsir f'sospensjoni li tintreħa bilmod għal injezzjoni.
English: The active substance in Abilify Maintena, aripiprazole, is an antipsychotic medicine.
Maltese: Is-sustanza attiva f'Abilify Maintena, l-aripiprażol, hija mediċina antipsikotika.
English: In one main study involving adults whose disease had already been stabilised on treatment with aripiprazole taken by mouth, 22 out of the 265 patients (8.3%) treated with Abilify Maintena had symptoms coming back within 26 weeks, compared with 21 out of 266 (7.9%) patients treated with aripiprazole taken by mouth.
Maltese: Fi studju ewlieni li involva adulti li l-marda tagħhom kienet diġà ġiet stabbilizzata fuq kura b'aripiprażol li jittieħed mill-ħalq, 22 minn 265 pazjent (8.3 %) ikkurati b'Abilify Maintena kellhom sintomi li reġgħu tfaċċaw fi żmien 26 ġimgħa, meta mqabbla ma' 21 minn 266 (7.9 %) pazjent ikkurati b'aripiprażol li jittieħed mill-ħalq.
English: In case of side effects, the dose may be reduced to 300 mg.
Maltese: F'każ ta' effetti sekondarji, id-doża tista' titnaqqas għal 300 mg.
English: This is a summary of the European public assessment report (EPAR) for Abilify Maintena.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Abilify Maintena.
English: Abilify Maintena is a medicine that contains the active substance aripiprazole.
Maltese: Abilify Maintena huwa mediċina li fiha s-sustanza attiva aripiprażol.
English: Other information about Abilify Maintena
Maltese: Informazzjoni oħra dwar Abilify Maintena
English: The European Commission granted a marketing authorisation valid throughout the European Union for Abilify Maintena on 15 November 2013.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Abilify Maintena fil-15 ta' Novembru 2013.
English: The most common side effects with Abilify Maintena (which may affect 5 or more people in 100) are increased weight, akathisia (a constant urge to move), insomnia (difficulty sleeping) and injection site pain.
Maltese: L-effetti sekondarji l-aktar komuni b'Abilify Maintena (li jistgħu jaffettwaw 5 jew aktar minn kull 100 persuna) huma żieda fil-piż, akatiżja (bżonn kostanti li tiċċaqlaq), insomnja (diffikultà biex torqod) u wġigħ fis-sit tal-injezzjoni.
English: Why is Abilify Maintena approved?
Maltese: Għaliex ġie approvat Abilify Maintena?
English: Schizophrenia is a mental illness with a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs).
Maltese: L-iskiżofrenija hija marda tal-moħħ b'għadd ta' sintomi, inklużi ħsibijiet u diskors diżorganizzati, alluċinazzjonijiet (tisma' jew tara affarijiet li mhumiex hemm), suspetti u delużjonijiet (twemmin falz).
English: The recommended dose is 400 mg once a month.
Maltese: Id-doża rakkomandata hija ta' 400 mg darba fix-xahar.
English: Since dopamine and 5hydroxytryptamine are involved in schizophrenia, aripiprazole helps to normalise the activity of the brain, reducing psychotic symptoms and preventing them from returning.
Maltese: Peress li d-dopamina u 5-idrossitriptamina huma involuti fl-iskiżofrenija, laripiprażol tgħin fin-normalizzazzjoni tal-attività tal-moħħ, billi tnaqqas is-sintomi psikotiċi u timpedixxi milli dawn jerġgħu jirritornaw.
English: The CHMP noted that Abilify Maintena is as effective as aripiprazole taken by mouth, and has a similar safety profile with the exception of injection pain, which was considered manageable.
Maltese: IsCHMP innota li Abilify Maintena huwa effettiv bħal aripiprażol li jittieħed mill-ħalq, u għandu profil tassigurtà simili bl-eċċezzjoni ta' uġigħ relatat mal-injezzjoni, li kien ikkunsidrat maniġġabbli.
English: How is Abilify Maintena used?
Maltese: Kif jintuża Abilify Maintena?
English: A risk management plan has been developed to ensure that Abilify Maintena is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Abilify Maintena jintuża bl-aktar mod sigur possibbli.
English: ‘Prolonged release' means that the active substance is released slowly over a few weeks after being injected.
Maltese: "Li tintreħa bil-mod" tfisser li s-sustanza attiva tintreħa bil-mod matul ftit ġimgħat wara li tiġi injettata.
English: After the first injection, daily treatment with 10 to 20 mg aripiprazole by mouth should be continued for 2 weeks.
Maltese: Wara l-ewwel injezzjoni, il-kura ta' kuljum b'10 sa 20 mg ta' aripiprażol mill-ħalq għandha titkompla għal ġimagħtejn.
English: Aripiprazole is thought to act mainly by being a ‘partial agonist' for the receptors for the neurotransmitters dopamine and 5-hydroxytryptamine (also called serotonin).
Maltese: Dan ifixkel is-sinjali trażmessi bejn iċ-ċelloli tal-moħħ permezz ta' ‘newrotrażmettituri', sustanzi kimiċi li jħallu liċ-ċelloli tan-nervituri tal-moħħ jikkomunikaw ma' xulxin.
English: The Committee considered that the monthly administration may help patients to adhere to their treatment.
Maltese: Jista' jkun li d-doża tkun teħtieġ titnaqqas f'pazjenti li jkunu qed jieħdu ċerti mediċini oħra li jnaqqsu t-tkissir tal-aripiprażol fil-ġisem.
English: What are the risks associated with Abilify Maintena?
Maltese: Kif jaħdem Abilify Maintena?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Abilify Maintena's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija iddeċieda li l-benefiċċji ta' Abilify Maintena huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: For the full list of all side effects reported with Abilify Maintena, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrapportati b'Abilify Maintena, ara l-fuljett ta' tagħrif.
English: Its exact mechanism of action is unknown, but it attaches to several receptors on the surface of nerve cells in the brain.
Maltese: Mhux magħruf ilmekkaniżmu tal-azzjoni eżatt tagħha, iżda teħel ma' diversi riċetturi differenti fuq is-superfiċje taċċelloli tan-nervituri tal-moħħ.
English: EMA/764518/2014 EMEA/H/C/002693
Maltese: EMEA/H/C/002693
English: The full EPAR for Fortacin 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: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom sprej plaċebo (finta) fuq 12-il ġimgħa.
English: Why is Fortacin approved?
Maltese: Għal xiex ġie approvat Fortacin?
English: Fortacin can only be obtained with a prescription and is available as a spray-on solution that supplies 7.5 mg of lidocaine and 2.5 mg of prilocaine per spray.
Maltese: Fortacin jista' jinkiseb biss b'riċetta ta' tabib u huwa disponibbli bħala soluzzjoni li tiġi sprejjata li tagħti 7.5 mg ta' lidocaine u 2.5 mg ta' prilocaine f'kull sprej.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Fortacin on 15 November 2013.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Fortacin fil-15 ta' Novembru 2013.
English: Other information about Fortacin
Maltese: Informazzjoni oħra dwar Fortacin
English: In the first study, the average time to ejaculation in patients treated with Fortacin was 2.6 minutes, compared with 0.8 minutes in those using placebo; in the second study, average ejaculation time in patients using the medicine was 3.8 minutes compared with 1.1 minutes in the placebo group.
Maltese: Fl-ewwel studju, il-ħin medju għall-eġakulazzjoni f'pazjenti li kienu qed jirċievu kura b'Fortacin kien ta' 2.6 minuti, meta mqabbla ma' 0.8 minuti f'dawk li kienu qed jużaw plaċebo; fit-tieni studju, il-ħin medju għall-eġakulazzjoni f'pazjenti li kienu qed jużaw il-mediċina kien ta' 3.8 minuti meta mqabbla ma' 1.1 minuti fil-grupp tal-plaċebo.
English: This is a summary of the European public assessment report (EPAR) for Fortacin.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Fortacin.
English: Some patients were monitored for up to 9 months in an extension of the initial studies and continued to show similar benefit.
Maltese: Xi pazjenti kienu mmonitorjati sa 9 xhur f'estensjoni tal-istudji inizjali u komplew juru benefiċċju simili.
English: The most common side effects with Fortacin (which may affect up to 1 in 10 people) are hypoaesthesia (reduced sensation) and a burning sensation in the genital area in both men and their female sexual partners, and erectile dysfunction (inability to maintain a normal erection) in men.
Maltese: L-effetti sekondarji l-aktar komuni b'Fortacin (li jistgħu jolqtu aktar minn persuna 1 minn kull 10) huma ipoestesija (sensazzjoni mnaqqsa) u sensazzjoni ta' ħruq fil-parti ġenitali kemm fl-irġiel kif ukoll fl-imsieħba sesswali nisa tagħhom, u disfunzjoni erettili (inabilità li tinżamm erezzjoni normali) fl-irġiel.
English: Fortacin is a medicine containing the active substances lidocaine and prilocaine.
Maltese: Fortacin huwa mediċina li fiha s-sustanzi attivi lidocaine u prilocaine.
English: The effectiveness of Fortacin has been shown in two main studies involving a total of 256 and 300 heterosexual adult men with premature ejaculation, respectively; both studies compared the medicine with a placebo (dummy) spray over 12 weeks.
Maltese: L-effikaċja ta' Fortacin ntweriet f'żewġ studji ewlenin li fihom ħadu sehem total ta' 256 u 300 raġel adult eterosesswali b'eġakulazzjoni prematura, rispettivament; iż-żewġ studji qabblu l-mediċina ma'
English: The active substances in the medicine, lidocaine and prilocaine, are local anaesthetics that temporarily numb the contact area by reversibly blocking the transmission of signals in the nerves.
Maltese: Is-sustanzi attivi fil-mediċina, lidocaine u prilocaine, huma anestetiċi lokali li temporanjament imewtu ż-żona ta' kuntatt billi b'mod riversibbli jimblokkaw it-trasmissjoni tas-sinjali fin-nervituri.
English: A risk management plan has been developed to ensure that Fortacin is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jassigura li Fortacin jintuża bl-aktar mod sigur possibbli.
English: What measures are being taken to ensure the safe and effective use of Fortacin?
Maltese: X'miżuri qegħdin jitteħdu biex jassiguraw użu sigur u effettiv ta' Fortacin??
English: There were positive psychological benefits to patients and their partners, and side effects were local and generally manageable.
Maltese: Kien hemm benefiċċji psikoloġiċi pożittivi għall-pazjenti u l-imsieħba tagħhom, u l-effetti sekondarji kienu lokali u ġeneralment maniġġevoli.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) considered that the active ingredients are a well-known local anaesthetic combination, and the use of a local spray minimises the amount of active substance absorbed and hence the risk of side effects affecting the body as a whole.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ikkunsidra li s-sustanzi attivi huma kombinazzjoni magħrufa ta' anestetiċi lokali, u l-użu ta' sprej lokali jnaqqas l-ammont tas-sustanza attiva li tiġi assorbita u b'hekk ir-riskju ta' effetti sekondarji li jaffettwaw il-ġisem kollu.
English: This summary was last updated in 09/2014.
Maltese: Is-sommarju ġie aġġornat l-aħħar fi: 09-2014.
English: How is Fortacin used?
Maltese: Kif jaħdem Fortacin?
English: Fortacin must not be used in patients who are hypersensitive (allergic) to any of the ingredients of the medicine or to other local anaesthetics with a structure related to the active ingredients (amide-type local anaesthetics).
Maltese: Fortacin m'għandux jintuża f'pazjenti li għandhom sensittività eċċessiva (allerġiċi) għal xi waħda mis-sustanzi tal-mediċina jew għal xi anestetiċi lokali oħra bi struttura relatata mas-sustanzi attivi (anestetiċi lokali tat-tip amide).
English: What are the risks associated with Fortacin?
Maltese: X'inhuma r-riskji assoċjati ma' Fortacin?
English: It is used to treat men with primary (lifelong) premature ejaculation (when ejaculation regularly occurs before, or too early during, penetration).
Maltese: Jintuża għall-kura ta' rġiel b'eġakulazzjoni prematura (meta l-eġakulazzjoni regolarment isseħħ qabel, jew kmieni wisq matul, ilpenetrazzjoni) primarja (tul il-ħajja).
English: The CHMP therefore decided that Fortacin's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Għalhekk, is-CHMP iddeċieda li l-benefiċċji ta' Fortacin huma akbar mirriskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: AT\BG\CZ\DK\FI\HR\HU\IS\NO\PL\ RO\SE\SI\SK
Maltese: AT\BG\CZ\DK\FI\HR\HU\
English: Ferric maltol is not systemically available.
Maltese: Ferric maltol mhuwiex sistemikament disponibbli.
English: Absorption and elimination
Maltese: Assorbiment u eliminazzjoni
English: Crospovidone (Type A)
Maltese: Crospovidone (Tip A)
English: Store below 25°C.
Maltese: Aħżen f'temperatura taħt 25 C.
English: Patheon France 40 boulevard de champaret 38300 Bourgoin-Jallieu FRANCE
Maltese: Patheon France 40 boulevard de champaret 38300 Bourgoin-Jallieu FRANZA
English: • Crospovidone (Type A)
Maltese: • Crospovidone (Tip A)
English: Reporting of suspected adverse reactions:
Maltese: Rappurtar ta' reazzjonijiet avversi suspettati: