FrancophonIA/ELRC3.0 huggingface dataset:
English: Incompatibilities:
Maltese: Inkompatibilitajiet maġġuri
English: Systemic absorption of hydrocortisone aceponate being negligible, it is unlikely for teratogenic, foetotoxic, maternotoxic effects to happen at the recommended dosage in dogs.
Maltese: Peress li l-assorbiment sistematiku tal-aċeponat idrokortison hu negliġibbli, mhux probabbli li jkun hemm effetti teratoġeniċi, fetutossiċi, matemotossiċi bid-dożaġġ rakkomandat fil-klieb.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of solution contains:
Maltese: U KWANTITATTIVA Milliltru wieħed fih:
English: PACKAGE SIZE
Maltese: TAL- PAKKETT
English: ADVERSE REACTIONS
Maltese: KONTRA-INDIKAZZJONIJIET
English: Tolerance studies using 3 and 5 times the recommended dosage for twice the recommended duration of treatment resulted in a reduced capacity for production of cortisol that is fully reversible within 7 to 9 weeks after the end of treatment.
Maltese: Studji ta' tolleranza li użaw 3 u 5 darbiet id-dożaġġ rakkomandat għal durazzjoni ta' trattament doppju rriżulta fi tnaqqis ta' kapaċità għal produzzjoni ta' kortisol li hu kompletament riversibbli fi żmien 7 sa 9 ġimgħat wara t-tmiem ta' trattament.
English: PHARMACEUTICAL FORM Cutaneous spray, solution.
Maltese: GĦAMLA FARMAĊEWTIKA Sprej kutanju, likwidu.
English: PHARMACOLOGICAL PROPERTIES
Maltese: FORMA FARMAĊEWTIKA
English: Hydrocortisone aceponate belongs to the diesters class of the glucocorticosteroids.
Maltese: Aċeponat idrokortison tappartjeni mal-klassi dijestri ta' glukokortikosterojdi.
English: The diesters are lipophilic components ensuring an enhanced penetration into the skin associated to a low plasma availability.
Maltese: Id-dijestri huma komponenti lipofiliċi li jassiguraw penetrazzjoni itjeb fil-ġilda assoċjata ma' disponibilità baxxa ta' plażma.
English: Do not use on cutaneous ulcers.
Maltese: Tużax fuq ulċeri kutanji.
English: Cardboard box containing 1 bottle of 76 ml.
Maltese: Kaxxa tal-kartun li fiha flixkun wieħed ta' 76 ml.
English: Cutaneous use.
Maltese: Mhux applikabbli.
English: 10 DATE OF REVISION OF THE TEXT <{MM/YYYY}> <{DD/MM/YYYY}> <{DD month YYYY}>
Maltese: DATA TA' META ĠIET RIVEDUTA DIN IL-KITBA <{XX/SSSS}>
English: The veterinary medicinal product contains the active substance hydrocortisone aceponate.
Maltese: Il-prodott mediċinali veterinarju fih is-sustanza attiva aċeponat idrokostison.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali veterinarju tinstab fuq il-websajt talAġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu/.
English: Hydrocortisone aceponate 0.584 mg Equivalent to 0.460 mg of hydrocortisone For the full list of excipients, see section 6.1.
Maltese: Ekwivalenti għal 0.460 mg ta' hydrocortisone Għal-lista sħiħa tal-ingredjenti (mhux attivi), ara sezzjoni 6.1.
English: STATEMENT OF ACTIVE SUBSTANCES Each ml contains 0.584 mg of hydrocortisone aceponate.
Maltese: Kull ml fih 0.584 mg ta' hydrocortisone aceponate.
English: 4.9 Amounts to be administered and administration route
Maltese: .9 Dożi rakkomandati u l-metodu ta' amministrazzjoni
English: Hydrocortisone aceponate applications on the skin lesions provide rapid reduction of the skin redness, irritation and scratching while minimising the general effects.
Maltese: Applikazzjonijiet l-aċeponat idrokortison fuq il-feriti fil-ġilda jipprovdu nuqqas rapidu ta' ħmura fil- ġilda, irritazzjoni u ħakk waqt it-tnaqqis tal-effetti ġenerali.
English: Hydrocortisone aceponate administered topically accumulates and is metabolised in skin, as suggested by radioactivity distribution studies and pharmacokinetic data.
Maltese: L-aċeponat idrokortison amministrat b'mod topiku jakkumula u jiġi mmetabolizzat fil-ġilda, kif issuġġerit mill-istudji ta' distribuzzjoni radjoattiva u informazzjoni farmakokinetika.
English: In the absence of specific information, the use in animal suffering from Cushing's syndrome shall be based on the risk-benefit assessment.
Maltese: Fl-assenza ta' informazzjoni speċifika, l-użu fl-annimali li jbatu mis-sindromu Cushing għandu jkun ibbażat fuq il-valutazzjoni ta' riskju-benefiċċju.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Cortacare 0.584 mg/ml cutaneous spray solution for dogs hydrocortisone aceponate
Maltese: VETERINARJU Cortacare 0.584 mg/ml sprej likwidu kutanju għall-klieb. aċeponat idrokortison
English: ANNEX II
Maltese: ANNES S II
English: White polyethylene terephthalate (PET) bottle closed with a white polypropylene screw cap with bore seal and supplied with a push in pump spray.
Maltese: Flixkun abjad tal-polyethylene terephthalate (PET) magħluq b'għatu tal-kamin abjad talpolypropylene b'siġill imtaqqab u fornut b'pompa tal-isprej.
English: In 12 dogs suffering from atopic dermatitis, after topical application on the skin at the recommended therapeutic dosage for 28 to 70 consecutive days, no noticeable effect on the systemic cortisol level was observed.
Maltese: Fi 12-il kelb li jbatu minn dermatite atopika, wara applikazzjoni topikali fuq il-ġilda biddoża rakkomandata terapewtika għal 28 sa 70 jum konsekuttiv, ma kienx hemm effett osservat fuq il-livell kortisol sistemiku.
English: For symptomatic treatment of inflammatory and pruritic dermatoses in dogs.
Maltese: Għat-trattament sintomatiku ta' dermatożi infjammatorji u pruritiċi fi klieb.
English: Topical application of diesters results in high therapeutic index: high local activity with reduced systemic secondary effects.
Maltese: Applikazzjoni topikali ta' dijestri tirriżulta f'indiċi terapewtika għolja: attività lokali għolja b'effetti sekondarji sistemiċi mnaqqsa.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Hydrocortisone aceponate 0.584 mg/ml.
Maltese: U INGREDJENT(I) OĦRA Aċeponat idrokortison 0.584 mg/ml
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Maltese: Tpejjipx waqt li tuża l-prodott mediċinali veterinarju.
English: In laboratory animals, hydrocortisone aceponate is eliminated the same way as hydrocortisone (other name for endogenous cortisol) through urine and faeces.
Maltese: Fl-annimali tallaboratorju, l-aċeponat idrokortison jiġi eliminat bl-istess mod bħal idrokortison (isem ieħor għal kortisol endoġenu) minn urina u ħara.
English: Propylene glycol methyl ether.
Maltese: EFFETTI MHUX MIXTIEQA
English: Otherwise, use only according to the risk-benefit assessment and subject the dog to regular clinical evaluations.
Maltese: Inkella, uża biss skont il-valutazzjoni ta' riskjubenefiċċju u ssuġġetta l-kelb għal evalwazzjonijiet kliniċi regolari.
English: Hydrocortisone aceponate is a dermocorticoid with a potent intrinsic glucocorticoid activity which means a relief of both inflammation and pruritus leading to a quick improvement of skin lesions observed in case of inflammatory and pruritic dermatosis.
Maltese: Aċeponat idrokortison hu dermokortikojd b'attività intrinsika glokokortikojdjali potenti li jfisser serħan kemm minn infjammazzjoni kif ukoll pruritu li jwassal għal titjib rapidu ta' feriti tal-ġisem osservati f'każ ta' dermatożi infjammattorji u pruritiki.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Cortacare 0.584 mg/ml cutaneous spray solution for dogs.
Maltese: VETERINARJU Cortacare 0.584 mg/ml sprej likwidu kutanju għall-klieb.
English: In case of conditions requiring an extended treatment, the responsible veterinarian should subject the use of the veterinary medicinal product to the risk-benefit assessment.
Maltese: F'każ ta' kondizzjonijiet fejn trattament imtawwal hu meħtieġ, il-veterinarju responsabbli għandu jissoġġetta l-użu tal-prodott mediċinali veterinarju għal valutazzjoni ta' riskjubenefiċċju.
English: The recommended dosage is 1.52 µg of hydrocortisone aceponate/cm2 of affected skin per day.
Maltese: Id-dożaġġ rakkomandat hu ta' 1.52 µg ta' aċeponat idrokortison/ċm tal-ġilda affettwata kuljum.
English: In the absence of information, it is recommended not to apply other topical preparations simultaneously on the same lesions.
Maltese: Fin-nuqqas ta' informazzjoni, hu rakkomandat li ma tapplikax sustanzi oħra topiċi simultanjament fuq l-istess feriti.
English: PACKAGE LEAFLET: Cortacare 0.584 mg/ml cutaneous spray solution for dogs
Maltese: FIL-PAKKETT Cortacare 0.584 mg/ml sprej likwidu kutanju għall-klieb.
English: Transient local reactions at the application site (erythema and/or pruritus) can occur in very rare cases.
Maltese: F'każijiet rari ħafna jista' jkun hemm reazzjonijiet lokali tranżitorji fis-sit tal-applikazzjoni (eritema u/jew ħakk).
English: Bioglan AB Borrgatan 31 211 24 Malmo Sweden
Maltese: FULJETT TA' TAGĦRIF DWAR T-TIKKETTAR U L-PAKKETT
English: Transient local reactions at the application site (erythema and/or pruritus) can occur in very rare cases
Maltese: F'każijiet rari ħafna jista' jkun hemm reazzjonijiet lokali tranżitorji fis-sit tal-applikazzjoni (eritema u/jew ħakk)
English: EXPIRY DATE EXP {month/year}
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI /
English: This dosage can be achieved with two pump hydrocortisone aceponate/cm spray activations over a surface to be treated equivalent to a square of 10 cm x 10 cm. Repeat the treatment daily for 7 consecutive days.
Maltese: Dan id-dożaġġ jista' jinkiseb b'żewġ attivazzjonijiet tal-pompa tal-isprej fuq superfiċju li għandu jiġi kkurat ekwivalenti ta' kwadru ta' 10ċm x 10ċm.
English: 6 August 2010
Maltese: 6 ta' Awwissu 2010
English: 1 Afibon, Ectiva, Lindaxa, Meissa, Meridia, Minimacin, Minimectil, Obesan, Sibutral, Sibutril, Siluton, Sitrane, Redoxade, Zelixa and Zelium.
Maltese: 1 Afibon, Ectiva, Lindaxa, Meissa, Meridia, Minimacin, Minimectil, Obesan, Sibutral, Sibutril, Siluton, Sitrane, Redoxade, Zelixa u Zelium.
English: What is sibutramine?
Maltese: X'inhu sibutramine?
English: Sibutramine is a ‘serotonin-noradrenaline re-uptake inhibitor' (SNRI).
Maltese: Sibutramine huwa ‘inibitur ta' teħid mill-ġdid ta' serotonin-noradrenaline' (SNRI).
English: Sibutramine-containing medicines have been authorised in the European Union (EU) since 1999.
Maltese: Mediċini li fihom sibutramine ilhom li ġew awtorizzati fl-Unjoni Ewropea (UE) sa mill-1999.
English: On the basis of these data, the German medicines regulatory agency (BfArM) triggered in November 2009 a review under Article 107 of Directive 2001/83/EC.
Maltese: Fuq il-bażi ta' dawn id-dejta, l-aġenzija regolatorja tal-mediċini Ġermaniża (BfArM) tat bidu, f'Novembru 2009, għal reviżjoni skont l-Artikolu 107 tad-Direttiva 2001/83/KE.
English: They are used, alongside diet and exercise, in patients who are obese (very overweight) with a body mass index (BMI) greater than or equal to 30 kg/m², and in patients who are overweight (with a BMI greater than or equal to 27 kg/m²) and also have other obesity-related risk factors, such as type 2 diabetes or dyslipidaemia (abnormal levels of fat in the blood).
Maltese: Jintużaw, flimkien ma' dieta u eżerċizzju, f'pazjenti li huma obeżi (li għandhom ħafna piż żejjed) b'indiċi tal-massa tal-ġisem (BMI - body mass index) ikbar minn jew ugwali għal 30 kg/m², u f'pazjenti li għandhom piż eċċessiv (b'BMI ikbar minn jew ugwali għal 27 kg/m²) u li għandhom ukoll fatturi ta' riskju relatati mal-obeżità oħrajn, bħal dijabete ta' tip 2 jew dislipidemija (livelli anormali ta' xaħam fid-demm).
English: The European Medicines Agency has completed a review of the safety and effectiveness of sibutramine.
Maltese: L-Aġenzija Ewropea tal-Mediċini temmet reviżjoni tas-sigurtà u tal-effikaċja ta' sibutramine.
English: Although the full data from the SCOUT study have not yet been analysed, the study's Data Safety Monitoring Board (a body of independent experts appointed to review regularly the outcome of the clinical trial) informed the Agency in October 2009 of preliminary data indicating that sibutramine is associated with more cardiovascular problems than placebo.
Maltese: Għalkemm id-dejta sħiħa mill-istudju SCOUT għadha ma ġietx analizzata, f'Ottubru 2009, il-Bord ta' Monitoraġġ tas-Sigurtà tad-Dejta tal-istudju (korp ta' esperti indipendenti maħtur sabiex jirrevedi b'mod regolari r-riżultat tal-prova klinika) informa lill-Aġenzija, bid-dejta preliminari li tindika li sibutramine huwa assoċjat ma' aktar problemi kardjovaskulari milli plaċebo.
English: Why was sibutramine reviewed?
Maltese: Għalfejn ġie rivedut sibutramine?
English: • Doctors should stop prescribing sibutramine-containing medicines to obese or overweight patients.
Maltese: • Spiżjar ma għandux iqassam iktar mediċini li fihom sibutramine.
English: Finally, looking at all of the studies of sibutramine in the management of obesity, the CHMP noted that the weight loss achieved with sibutramine treatment is modest in comparison with that obtained with placebo, with patients losing on average two to four kilograms more than with placebo.
Maltese: Finalment, meta ħares lejn l-istudji kollha ta' sibutramine fil-ġestjoni tal-obeżità, is-CHMP innota li t-telf fil-piż miksub b'kura b'sibutramine huwa wieħed modest meta mqabbel ma' dak li nkiseb bi plaċebo, bil-pazjenti jitilfu bħala medja żewġ kilogrammi sa erba' kilogrammi aktar milli bilplaċebo.
English: They are available as capsules containing 10 mg or 15 mg sibutramine, under the trade names Reductil and other names1, and as generic medicines.
Maltese: Jiġu bħala kapsuli li fihom 10 mg jew 15 mg sibutramine, taħt l-ismijiet kummerċjali Reductil u l-ismijiet assoċjati1, u bħala mediċini ġeneriċi.
English: Questions and answers on the suspension of medicines containing sibutramine
Maltese: Mistoqsijiet u tweġibiet dwar is-sospensjoni tal-mediċini li fihom sibutramine
English: The CHMP reviewed the responses from the company to a list of questions on the SCOUT study.
Maltese: Is-CHMP irreveda r-rispons mill-kumpanija għal lista ta' mistoqsijiet dwar l-istudju SCOUT.
English: In total, about 9,800 patients have been followed up for six years.
Maltese: B'kollox, madwar 9,800 pazjent ġew segwiti għal massimu ta' sitt snin.
English: The Committee also consulted a group of experts specialising in the treatment of metabolic diseases.
Maltese: Il-Kumitat ikkonsulta wkoll lil grupp ta' esperti li jispeċjalizzaw fil-kura ta' mard metaboliku.
English: The CHMP noted that the SCOUT study showed an increased risk of serious cardiovascular events (such as heart attack or stroke) in patients with known cardiovascular disease taking sibutramine.
Maltese: Is-CHMP innota li l-istudju SCOUT wera riskju miżjud ta' episodji kardjovaskulari serji (bħal attakk tal-qalb jew puplesija) f'pazjenti b'mard kardjovaskulari magħruf li jieħdu sibutramine.
English: It works by preventing the neurotransmitters 5-hydroxytryptamine (also called serotonin) and noradrenaline from being taken back up into nerve cells in the brain.
Maltese: In-newrotrasmettituri huma kimiċi li jippermettu liċ-ċelloli tan-nervituri sabiex jikkomunikaw bejniethom.
English: Sibutramine was originally reviewed by the Agency in 1999 and 2002, following concerns over its safety, especially cardiovascular side effects (increased blood pressure and heart rate).
Maltese: Sibutramine ġie rivedut oriġinarjament mill-Aġenzija fl-1999 u l-2002, wara tħassib fuq is-sigurtà tiegħu, b'mod speċjali l-effetti kardjovaskulari sekondarji (żieda fil-pressjoni tad-demm u fir-rata
English: The study compared sibutramine with placebo (a dummy treatment), and looked not only at how much weight the patients were losing, but also at the occurrence of cardiovascular events, such as heart attack, stroke and cardiac arrest.
Maltese: L-istudju qabbel sibutramine ma' plaċebo (trattament finta), u ħares mhux biss lejn kemm piż kienu qegħdin jitilfu l-pazjenti, iżda wkoll lejn is-seħħ ta' episodji kardjovaskulari, bħal attakk tal-qalb, puplesija u arrest kardijaku.
English: Most of the patients in the SCOUT study would not normally be given sibutramine, as the medicine is contra-indicated in patients with cardiovascular disease.
Maltese: Ħafna mill-pazjenti fl-istudju SCOUT normalment jingħataw sibutramine, minħabba li l-mediċina hija kontra-indikata f'pazjenti b'mard kardjovaskulari.
English: The full EPAR for Inhixa 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 reference medicine for Inhixa is Clexane.
Maltese: Il-mediċina ta' referenza għal Inhixa hija Clexane.
English: The active substance in Inhixa is enoxaparin sodium.
Maltese: Is-sustanza attiva f'Inhixa hija enoxaparin sodium.
English: Extensive laboratory studies comparing Inhixa with Clexane have shown that Inhixa is highly similar to Clexane in terms of structure, purity and biological activity.
Maltese: Studji estensivi fil-laboratorju li jqabblu Inhixa ma' Clexane urew li Inhixa huwa simili ħafna għal Clexane f'termini ta' struttura, purità u attività bijoloġika.
English: The most common side effect with Inhixa (which may affect more than 1 in 10 people) is haemorrhage (bleeding); serious bleeding occurred in around 4 people in 100 given Inhixa to prevent blood clots during surgery.
Maltese: L-effetti sekondarju l-aktar komuni b'Inhixa (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma emorraġija (fsada); seħħet fsada serja f'madwar 4 minn kull 100 li ngħataw Inhixa biex jiġu evitati l-emboli tad-demm waqt kirurġija.
English: The active substance in Inhixa, enoxaparin, is one of a group of anticoagulant medicines called ‘low-molecular weight heparins'.
Maltese: Is-sustanza attiva f'Inhixa, enoxaparin, hija waħda minn grupp ta' mediċini antikoagulanti msejjaħ "eparina ta' piż molekulari baxx".
English: This is a summary of the European public assessment report (EPAR) for Inhixa.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Inhixa.
English: Why is Inhixa approved?
Maltese: Għaliex ġie approvat Inhixa?
English: • to treat certain types of myocardial infarction (heart attack);
Maltese: • biex jikkura ċerti tipi ta' infart mijokardijaku (attakk tal-qalb);
English: For more information on biosimilar medicines, see the question-and-answer document here.
Maltese: Għal aktar informazzjoni dwar il-mediċini bijosimili, ara ddokument mistoqsija u tweġiba hawn
English: It is usually given as an injection under the skin although in the treatment of a type of heart attack called acute ST-segment elevation myocardial infarction (STEMI) it is first given as an injection into a vein, and to prevent clots in haemodialysis machines it is injected directly into the tube carrying the blood.
Maltese: Dan normalment jingħata bħala injezzjoni taħt il-ġilda għalkemm fil-kura ta' tip ta' attakk tal-qalb imsejjaħ infart mijokardijaku b'elevazzjoni tas-segment ST (STEMI) akut l-ewwel jingħata bħala injezzjoni fil-vina, u sabiex jiġu evitati emboli fil-magni tal-emodijaliżi dan jiġi injettat direttament fit-tubu li jġorr id-demm.
English: What are the risks associated with Inhixa?
Maltese: X'inhuma r-riskji assoċjati ma' Inhixa?
English: • to treat conditions associated with blood clots such as deep vein thrombosis (where the clot develops in a deep vein, usually in the leg);
Maltese: • biex jikkura kundizzjonijiet assoċjati ma' emboli tad-demm bħal trombożi profonda fil-vini (fejn l embolu jifforma f'vina profonda, normalment fis-sieq)
English: It is used in adults for the following:
Maltese: Jintuża fl-adulti għal li ġej:
English: Inhixa is an anticoagulant medicine (a medicine to prevent blood clots).
Maltese: Inhixa huwa mediċina antikoagulanti (mediċina biex tipprevjeni emboli tad-demm).
English: This means that Inhixa is highly similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Maltese: Dan ifisser li Inhixa huwa simili għal mediċina bijoloġika (magħrufa wkoll bħala l-"mediċina ta' referenza") li diġà hija awtorizzata fl-Unjoni Ewropea (UE).
English: • to treat unstable angina (a severe type of chest pain caused by problems with the blood flow to the heart);
Maltese: • biex jikkura anġina instabbli (tip sever ta' uġigħ fis-sider kkawżat minn problemi fil-fluss tad-demm lejn il-qalb);
English: Other information about Inhixa
Maltese: Informazzjoni oħra dwar Inhixa:
English: Inhixa is a ‘biosimilar medicine'.
Maltese: Inhixa huwa "mediċina bijosimili".
English: Therefore, the Agency's Committee for Medicinal Products for Human Use (CHMP) considered that there are no clinically meaningful differences between Inhixa and Clexane in terms of effectiveness and safety and took the view that, as for Clexane, the benefit outweighs the identified risk.
Maltese: Għalhekk, il-Kumitat tal-Aġenzija għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) qies li m'hemm l-ebda differenza klinikament sinifikanti bejn Inhixa u Clexane f'termini ta' effettività u sigurtà u kien tal-fehma li, għal Clexane, il-benefiċċju huwa akbar mir-riskju identifikat.
English: The safety profiles of the two medicines were also considered similar, based on laboratory testing.
Maltese: Il-profili ta' sigurtà taż-żewġ mediċini wkoll tqiesu simili, skont l-ittestjar tal-laboratorju.
English: How does Inhixa work?
Maltese: Kif jaħdem Inhixa?
English: • to prevent venous thromboembolism (blood clots that form inside the veins, obstructing blood flow), especially in patients who are having surgery or who are at greater risk of clots because they are bedridden due to illness;
Maltese: • biex jipprevjeni tromboemboliżmu (emboli tad-demm li jiffurmaw ġol-vini, li jfixklu l-fluss tad demm), speċjalment f'pazjenti li jkunu qed jiġu operati jew li jkunu jinsabu f'riskju akbar ta' emboli minħabba li ilhom għal żmien twil fis-sodda minħabba l-mard;
English: Enoxaparin increases the effect of antithrombin III, a natural substance that controls the blood's clotting factors and helps prevent blood from clotting inside the body.
Maltese: Enoxaparin iżid l-effett ta' antithrombin III, sutanza naturali li tikkontrolla l-fatturi tal-għaqid tad-demm u tgħin tipprevjeni biex id-demm ma jagħqadx fil-ġisem.
English: • to prevent clots forming when blood is circulated through a haemodialysis machine to remove toxic substances.
Maltese: • biex jipprevjeni milli jiffurmaw emboli meta d-demm jiġi ċċirkolat permezz ta' magna tal emodijaliżi biex jitneħħew sustanzi tossiċi.
English: Doses must be adjusted in patients with severely reduced kidney function.
Maltese: Id-dożi għandhom jiġu aġġustati f'pazjenti bi tnaqqis gravi fil-funzjoni tal-kliewi.
English: In addition, increased levels of liver enzymes in the blood (a sign of possible liver problems) are very common (may affect more than 1 in 10 people).
Maltese: Barra minn hekk, il-livelli miżjuda ta' enzimi tal-fwied fiddemm (sinjal ta' problemi possibbli fil-fwied) huma komuni ħafna (jistgħu jaffettwaw aktar minn persuna 1 minn kull 10).
English: For practical information about using Inhixa, patients should read the package leaflet or contact their doctor or pharmacist.
Maltese: Il-kumpanija pprovdiet ukoll informazzjoni minn studji ppubblikati li turi l-benefiċċji ta' enoxaparin filprevenzjoni u fil-kura ta' emboli tad-demm.
English: EMA/43226/2016 EMEA/H/C/000488
Maltese: EMA/43226/2016 EMA/H/C/000488
English: The full EPAR for Vivanza 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: Vivanza is a medicine that contains the active substance vardenafil.
Maltese: Vivanza huwa mediċina li fiha s-sustanza attiva vardenafil.
English: It is available as film-coated tablets (5, 10 and 20 mg) and as orodispersible tablets (10 mg).
Maltese: Jiġi bħala pilloli miksijin b'rita (5, 10 u 20 mg) u bħala pilloli orodispersibbli (10 mg).
English: The active ingredient of Vivanza, vardenafil, belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Maltese: Is-sustanza attiva f'Vivanza, il-vardenafil, hi parti minn grupp ta' mediċini magħruf bħala inibituri fosfodjesterażi tat-tip 5 (PDE5) (phosphodiesterase type 5 (PDE5) inhibitors).