FrancophonIA/ELRC3.0 huggingface dataset:
English: Halocur is used in newborn calves to prevent or reduce diarrhoea due to an organism called Cryptosporidium parvum.
Maltese: Halocur jintuża fil-prevenzjoni u t-tnaqqis tad-dijarea kkawżata minn organiżmu magħruf bħala Cryptosporidium parvum fl-għoġġiela tat-twelid.
English: Another trial of calves aged from 24 to 48 hours demonstrated that Halocur can prevent diarrhoea due to Cryptosporidium parvum compared with placebo.
Maltese: Fi studju ieħor ta' l-għoġġiela ta' bejn 24 u 48 siegħa intwera li Halocur jista' jipprevjeni d-dijarea kkawżata minn Cryptosporidium parvum meta mqabbel mal-plaċebo.
English: It also prevents it from forming oocysts, which are formed at a certain stage in the lifecycle of the parasite and are excreted (shed) in the faeces.
Maltese: Tipprevjeni wkoll il-formazzjoni ta' oocysts, li jiffurmaw f'ċertu stadju fiċ-ċiklu tal-ħajja tal-parassita u jinħarġu mill-ġisem fl-ippurgar.
English: This document is a summary of the European Public Assessment Report.
Maltese: Dan id-dokument huwa sommarju tar-Rapport tal-Valutazzjoni Pubblika Ewropew.
English: Clinical signs of Cryptosporidium parvum infection are seen mainly as diarrhoea.
Maltese: Issinjal kliniku ewlieni ta' l-infezzjoni bi Cryptosporidium parvum huwa d-dijarea.
English: Halocur is presented as a clear, yellow solution for administration by mouth.
Maltese: Holavur jiġi bħala soluzzjoni ċara safra, għall-amministrazzjoni orali.
English: 1 pre-filled syringe (singledose)
Maltese: siringa 1 mimlija għallest (doża waħda)
English: 1 pre-filled pen (single-dose)
Maltese: Numru tal-MA (EU) Isem (ivvintat) Qawwa Għamla farmaċewtika
English: Alcon Cusí, S.A., Camil Fabra 58, 08320 El Masnou, Barcelona, Spain.
Maltese: Alcon Cusí, S.A., Camil Fabra 58, 08320 El Masnou, Barcelona, Spanja.
English: ATC code: S01G X 06.
Maltese: S01G X 06.
English: Manufacturer Alcon Cusí, S.A., Camil Fabra 58, 08320 El Masnou, Spain
Maltese: Manifattur Alcon Cusí, S.A., Camil Fabra 58, 08320 El Masnou, Spanja
English: purified water.
Maltese: hypromellose; purified water.
English: 4.9 Overdose
Maltese: .9 Doza eċċessiva
English: EMADINE is supplied in packs containing 30 or 60 units.
Maltese: EMADINE huwa disponibbli f'pakketti li fihom 30 jew 60 kontenitur.
English: EMADINE contains benzalkonium chloride
Maltese: EMADINE fih benzalkonium chloride
English: Contains: benzalkonium chloride 0.1 mg/ml, trometamol, sodium chloride, hypromellose, hydrochloric acid/sodium hydroxide, purified water.
Maltese: Fih: benzalkonium chloride 0.1 mg/ml, trometamol, sodium chloride, hypromellose, hydrochloric acid/sodium hydroxide, ilma ppurifikat.
English: Emedastine is a potent selective and topically effective histamine H1 antagonist (Ki = 1.3 nM).
Maltese: Emedastine huwa antagonista ta' histamine H1 (Ki = 1.3 nM) potenti, selettiv u effettiv b'mod topiku.
English: B-2870 Puurs, Belgium
Maltese: B-2870 Puurs, Il-Belġju
English: Pharmacotherapeutic group: decongestants and antiallergics; other antiallergics.
Maltese: Kategorija farmakoterapewtika: dekonġestjonanti u mediċini kontra l-allerġiji; mediċini kontra lallerġiji oħra.
English: They are ranked according to system organ class and classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000), or not known (cannot be estimated from the available data).
Maltese: Huma mqassma skond is-sistema tal-klassifika tal-organi u kklassifikati skond ilkonvenzjoni li ġejja: komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1000 sa <1/100), rari (≥1/10,000 sa <1/1000), rari ħafna (<1/10,000), jew mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: B-2870 Puurs, Belgium.
Maltese: B-2870 Puurs, Il-Belġju.
English: Benzalkonium chloride, which is commonly used as a preservative in ophthalmic products, has been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy.
Maltese: Benzalkonium chloride li jintuża b'mod komuni bħala preservattiv fi prodotti għall-għajnejn, kien irrapportat li jikkawża punctate keratopathy u/jew keratopatija ulċerattiva tossika.
English: Uncommon rash
Maltese: Mhux komuni raxx
English: In vitro examinations of emedastine's affinity for histamine receptors (H1, H2, and H3) demonstrate 10,000-fold selectivity for the H1 receptor, Ki's = 1.3 nM, 49,064 nM and 12, 430 nM, respectively.
Maltese: In vitro, dwar l-affinità ta' emedastine għal riċetturi ta' histamine (H1, H2, u H3) juru selettività ta' 10,000 darba iktar għar-riċettur H1, Ki's=1.3 nM, 49,064 nM u 12, 430 nM rispettivament.
English: • Tear off the foil wrapper and take out the strip of 5 containers.
Maltese: • Iftaħ il-pakkett tal-fojl u oħroġ l-istrippa ta' 5 kontenituri.
English: In vitro examinations of emedastine's affinity for histamine receptors (H1, H2, and H3) demonstrate 10,000-fold selectivity for the H1 receptor, Kis = 1.3 nM, 49,064 nM and 12, 430 nM, respectively.
Maltese: In vitro, dwar l-affinità ta' emedastine għal riċċeturi ta' histamine (H1, H2, u H3) juru selettività ta' 10,000 darba iktar għar-riċċettur tat-tip H1, Kis=1.3 nM, 49,064 nM u 12, 430 nM rispettivament.
English: The 5-oxo analogues of 5-and 6-hydroxyemedastine and the N-oxide are also formed as minor metabolites.
Maltese: L-analogi 5'-oxo ta' 5-u 6-hydroxyemedastine u l-N-Oxide wkoll huma iffurmati bħala metaboliti minuri.
English: The recommended dose < see side 1
Maltese: Id-doża rrakkomandata <ara naħa 1
English: EMADINE 0.5 mg/ml eye drops, solution S.A. Alcon-Couvreur N.V., Rijksweg 14,
Maltese: EMADINE 0.05 mg/ml qtar għall-għajnejn, soluzzjoni S.A. Alcon-Couvreur N.V., Rijksweg 14,
English: Carton for 30 x 0.35 ml containers & carton of 60 x 0.35 ml containers
Maltese: Kartuna għal 30 kontenitur ta' 0.35 ml & kartuna għal 60 kontenitur ta' 0.35 ml
English: BOTTLE LABEL 5 ml & 10 ml
Maltese: TIKKETTA TAL-FLIXKUN 5 ml & 10 ml
English: There was no evidence of impaired fertility or decreased reproductive capacity in rats administered oral dosages of Emedastine difumarate of up to 30 mg/kg/day.
Maltese: Ma kien hemm l-ebda evidenza ta' indeboliment fil-fertilità jew tnaqqis fil-kapaċità riproduttiva filfirien li ngħataw dożi orali ta' Emedastine difumarate sa 30 mg/kg/jum.
English: Not known tachycardia
Maltese: Mhux magħruf takikardija
English: Contains: trometamol, sodium chloride, hypromellose, hydrochloric acid, sodium hydroxide and purified water.
Maltese: Fih: Trometamol, sodium chloride, hypromellose, hydrochloric acid/sodium hydroxide u ilma ppurifikat.
English: 1 ml of solution contains emedastine 0.5 mg (as difumarate).
Maltese: U KWANTITATTIVA 1 ml ta' soluzzjoni fih 0.5 mg emedastine (bħala difumarate).
English: Hydrochloric acid/sodium hydroxide (to adjust pH) Purified water
Maltese: Hydrochloric acid/sodium hydroxide (għall-aġġustament tal-pH) Ilma ppurifikat
English: Samples in which emedastine was quantifiable ranged from 0.30 to 0.49 ng/ml.
Maltese: Kampjuni fejn emedastine seta' jiġi kwantifikat varjaw minn 0.3 sa 0.49 ng/ml.
English: Emedastine 0.5 mg/ml as difumarate
Maltese: Emedastine 0.5 mg/ml bħala difumarate
English: The following pack sizes are available: 30 x 0.35 ml single-dose containers and 60 x 0.35 ml single-dose containers.
Maltese: Hemm disponibbli dawn id-daqsijiet tal-pakkett: 30 kontenitur ta' 0.35 ml b'doża waħda; u 60 kontenitur ta' 0.35 ml b'doża waħda.
English: In clinical trials, approximately 7% of patients experienced an adverse drug reaction associated with the use of Emadine; however, less than 1% of these patients discontinued therapy due to these adverse drug reactions.
Maltese: Fi provi kliniċi, madwar 7% tal-pazjenti kellhom esperjenza ta' reazzjoni avversa tal-mediċina assoċjata ma' l-użu ta' Emadine; iżda, inqas minn 1% ta' dawn ilpazjenti waqqfu t-terapija minħabba dawn ir-reazzjonijiet avversi tal-mediċina.
English: Emedastine was found to increase the QT interval in dogs; the NOEL corresponds to levels 23-fold higher than those found in patients (7 ng/ml as compared with 0.3 ng/ml, i.e., the limit of detection for emedastine).
Maltese: Emedastine instab li jżid l-intervall tal-QT fil-klieb; NOEL jikkorrispondi għal-livelli 23-darba ogħla minn dawk osservati f'pazjenti (7 ng/ml kif imqabbel ma' 0.3 mg/ml, i.e., il-limitu tal-livell biex jiġi identifikat emedastine).
English: How to store EMADINE
Maltese: Tużax EMADINE
English: The drop will go in here (picture 1).
Maltese: Il-qatra se tmur hawn (stampa 1).
English: In vivo topical ocular administration of emedastine produces a concentration-dependent inhibition of histamine-stimulated conjunctival vascular permeability.
Maltese: In vivo, l-għoti topiku fl-għajnejn ta' emedastine jipproduċi inibizzjoni dipendenti millkonċentrazzjoni tal-permeabilità vaskulari tal-konġuntiva li hija stimulata mill-istamina.
English: In a teratology study in rats, foetotoxic but not teratogenic effects were observed at the highest dose evaluated (140 mg/kg/day); no effects were observed at a lower level (40 mg/kg/day) which corresponds to an exposure well in excess of that produced by the therapeutic recommended dose.
Maltese: Fi studju teratoloġiku fil-firien, fl-ogħla doża evalwata (140 mg/kg/kuljum), kienu osservati effetti tossiċi fil-fetu iżda ma kienux osservati effetti teratoġeniċi; f'livell inqas (40 mg/kg/kuljum) li jikkorrispondi għall-esponiment ferm ogħla minn dak li jintlaħaq bid-doża terapewtika rrakkomandata, ma kienux osservati effetti.
English: For ocular use.
Maltese: Mhux applikabbli.
English: Mean peak plasma levels were approximately 1 ng/ml and 2 ng/ml for the 0.5 and 1.0 mg/ml treatments respectively.
Maltese: Il-medja ta' l-għola livelli fil-plażma kienu kważi 1 ng/ml u 2 ng/ml għall-kura b'0.5 u 1.0 mg/ml rispettivament.
English: In 13 clinical studies involving 696 patients, Emadine was administered one to four times daily in both eyes for up to 42 days.
Maltese: Fi 13-il studju kliniku li nvolva 696 pazjent, Emadine ingħata minn darba sa erba' darbiet kuljum fiżżewġ għajnejn għal tul sa 42 ġurnata.
English: Symptomatic treatment of seasonal allergic conjunctivitis.
Maltese: Kura sintomatika ta' konġuntivite allerġika ta' l-istaġun.
English: This medicine contains 0.5 mg or 1 mg benzalkonium chloride in each 5 or 10 ml, which are equivalent to 0.1 mg/ml.
Maltese: Din il-mediċina fiha 0.5 mg jew 1 mg ta' benzalkonium chloride f'kull 5 jew 10 ml, li hu ekwivalenti għal 0.1 mg/ml.
English: - The other ingredients are benzalkonium chloride, trometamol; sodium chloride; hypromellose;
Maltese: - Is-sustanzi mhux attivi l-oħra ħuma benzalkonium chloride, trometamol; sodium chloride;
English: Corneal limbal mononuclear cell infiltrates were noted in 1/4 male monkeys treated with 0.5 mg/ml and in 4/4 males and 1/4 females treated with1.0 mg/ml.
Maltese: Kienu osservati corneal limbal mononuclear cell infiltrates f'1/4 tax-xadini maskili li ġew ikkurati b'0.5 mg/ml u f'4/4 ta' l-irġiel u f'1/4 tan-nisa li ġew ikkurati b'1.0 mg/ml.
English: What EMADINE contains - The active substance is emadastine 0.5 mg/ml as difumarate.
Maltese: X'fih EMADINE - Is-sustanza attiva hi emedastine 0.5 mg/ml bħala difumarate.
English: Emedastine difumarate demonstrated low acute toxicity in a number of species by various routes of administration.
Maltese: Emedastine difumarate kellu tossiċità akuta baxxa f'numru ta' speċi meta ingħata minn rotot differenti.
English: • Effects in the eye: corneal disorder, abnormal eye sensation, increased tear production, tired eyes, eye irritation, blurred vision, corneal staining, dry eye.
Maltese: • Effetti fl-għajn: disturb fil-kornea, sensazzjoni mhux normali fl-għajn, żieda fil-produzzjoni ta' dmugħ, għeja fl-għajnejn, irritazzjoni fl-għajn, vista mċajpra, tebgħa fil-kornea, għajn tinħass xotta.
English: The most common adverse drug reactions were eye pain and eye pruritus occurring in 1% to 2.0% of patients.
Maltese: L-aktar reazzjonijiet avversi tal-mediċina komuni kienu uġigħ fl-għajn u ħakk fl-għajn li seħħew f'1% sa 2.0% tal-pazjenti.
English: In a study involving ten normal volunteers dosed bilaterally twice daily for 15 days with EMADINE 0.5 mg/ml eye drops solution, plasma concentrations of the parent compound were generally below the quantitation limit of the assay (0.3 ng/ml).
Maltese: Fi studju li sar fuq għaxar voluntiera normali li ġew mogħtija EMADINE 0.5 mg/ml qtar għall-għajnejn darbtejn kuljum f'għajnejhom it-tnejn għal 15-il ġurnata, l-konċentrazzjoni fil-plażma tas-sustanza oriġinali ġeneralment kienet inqas mil-limitu kwantitattiv ta' l-analiżi (0.3 ng/ml).
English: Preservative free.
Maltese: Ma fihx preservattivi.
English: Two primary metabolites, 5-and 6-hydroxyemedastine, are excreted in the urine as both free and conjugated forms.
Maltese: Żewġ metaboliti primarji, 5-u 6-hydroxy-emedastine, jitneħħew fl-awrina kemm bħala forom ħielsa kif ukoll konjugati.
English: System Organ Classification
Maltese: Klassifika tas-Sistemi u tal-Organi
English: EMADINE Ocular use
Maltese: Sustanzi mhux attivi
English: Date of first authorisation: 27 January 1999 Date of latest renewal: 13 January 2009
Maltese: Data tal-aħħar tiġdid: 13 ta' Jannar 2009
English: • EMADINE is not recommended for use in patients over 65 years of age, as it has not been studied in clinical trials in this age group.
Maltese: • EMADINE mhux irrakkomandat għall-użu f'pazjenti b'età 'l fuq minn 65 sena għax fl-istudji kliniċi ma kienx studjat f'pazjenti ta' din l-età.
English: EMADINE is supplied in low density polyethylene single-dose containers which contain 0.35 ml.
Maltese: EMADINE huwa likwidu (soluzzjoni) disponibbli f'kontenituri tal-plastik b'doża waħda b'volum ta' 0.35 ml.
English: Emedastine is principally metabolised by the liver.
Maltese: Emedastine huwa metabolizzat prinċipalment mill-fwied.
English: Foil Pouch
Maltese: U L-UŻU
English: The preservative in EMADINE, benzalkonium chloride, may be absorbed by soft contact lenses and may change the colour of the contact lenses.
Maltese: Il-preservattiv f'EMADINE, benzalkonium chloride jista' jigi assorbit mil-lentijiet tal-kuntatt rotob u jista' jbiddel il-kulur tal-lentijiet tal-kuntatt.
English: In addition benzalkonium chloride may cause eye irritation and is known to discolour soft contact lenses.
Maltese: Barra dan benzalkonium chloride jista' jikkawża irritazzjoni fl-għajn u huwa magħruf li jbiddel ilkulur ta' lentijiet tal-kuntatt rotob.
English: Uncommon corneal infiltrates, corneal staining, blurred vision, eye irritation, dry eye foreign body sensation in eyes, lacrimation increased, asthenopia, ocular hyperaemia
Maltese: Mhux komuni infiltrati fil-kornea, tbajja filkornea, vista mċajpra, irritazzjoni fl-għajn, għajn tinħass xotta, sensazzjoni ta' oġġett barrani fl-għajnejn, żieda fid-dmugħ, astenopija, iperimija tal-għajn
English: EMADINE is supplied in 5 ml and 10 ml opaque plastic DROP-TAINER bottles.
Maltese: EMADINE huwa likwidu (soluzzjoni) disponibbli f'pakkett li fih flixkun tal-plastik (DROP-TAINER) ta' 5 ml jew 10 ml b'għatu bil-kamin.
English: Ocular corneal infiltrates
Maltese: Disturbi fil-qalb
English: Do not use EMADINE after the expiry date which is stated on the bottle and box after “EXP”.
Maltese: Tużax EMADINE wara d-data ta' meta tiskadi li tidher fuq il-flixkun u l-kaxxa wara “EXP”.
English: PHARMACOLOGICAL PROPERTIES
Maltese: TA' PRODOTTI MEDIĊINALI MHUX
English: • General side effects: headache, difficulty sleeping, sinus headache, bad taste, rash
Maltese: • Effetti sekondarji ġenerali: uġigħ ta' ras, diffikultà biex torqod, uġigħ ta' ras mis-sinusis, togħma ħażina, raxx
English: EMADINE 0.5 mg/ml eye drops, solution, single-dose container emedastine
Maltese: EMADINE 0.5 mg/ml qtar għall-għajnejn, soluzzjoni, kontenitur b'doża waħda emedastine
English: B. PACKAGE LEAFLET
Maltese: Pakkett tal-fojl
English: • If you wear contact lenses please see section ‘EMADINE contains benzalkonium chloride below'.
Maltese: • Jekk tuża lentijiet tal-kuntatt jekk jogħġbok ara s-sezzjoni ‘EMADINE fih benzalkonium chloride' taħt.
English: Scleral mononuclear cell infiltrates were present in 1/4 males and 1/4 females treated with 0.5 mg/ml and in 2/4 males and 1/4 females treated with1.0 mg/ml.
Maltese: Scleral mononuclear cell infiltrates kienu preżenti f'1/4 ta' l-irġiel u f'1/4 tan-nisa li ġew ikkurati b'0.5 mg/ml u f'2/4 ta' l-irġiel u f'1/4 tan-nisa li ġew ikkurati b'1.0 mg/ml.
English: The recommended dose is in adults and children over 3 years: One drop in the eye, twice a day.
Maltese: Id-doża rrakkomandata fl-adulti u tfal ta' aktar minn 3 snin:
English: • Gently squeeze the container to release one drop into the pocket between the eyelid and eye (picture 3).
Maltese: • Għafas il-kontenitur bil-mod biex tinżel qatra waħda fl-ispazju bejn il-kappell t'għajnek u l għajn (stampa 3).
English: Uncommon abnormal dreams
Maltese: Mhux komuni ħolm mhux normali
English: Read the package leaflet before use.
Maltese: Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu fissuq.
English: • Throw away the container and any leftover solution at once.
Maltese: • Armi l-kontenitur u s-soluzzjoni li jifdal immedjatament.
English: EMADINE 0.5 mg/ml eye drops, solution emedastine
Maltese: EMADINE 0.5 mg/ml qtar għall-għajnejn, soluzzjoni emedastine
English: Allergic conjunctivitis.
Maltese: Allerġija fil-konġuntiva:
English: - The other ingredients are trometamol; sodium chloride; hypromellose; purified water.
Maltese: - Is-sustanzi mhux attivi l-oħra huma trometamol; sodium chloride; hypromellose; ilma ppurifikat.
English: Tiny amounts of hydrochloric acid or sodium hydroxide are sometimes added to keep acidity levels (pH levels) normal
Maltese: Xi kultant jiżdiedu ammonti żgħar ta' hydrochloric acid jew sodium hydroxide biex iżommu l-livelli tal-aċidità (livelli tal-pH) normali.
English: Common side effects (may affect up to 1 in 10 people) • Effects in the eye: eye pain, itchy eye, eye redness
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa persuna waħda minn kull 10)
English: EMADINE 0.5 mg/ml eye drops, solution, single-dose container.
Maltese: EMADINE 0.05 mg/ml qtar għall-għajnejn, soluzzjoni, kontenitur b'doża waħda.
English: Ocular corneal infiltrates were reported in conjunction with the use of EMADINE.
Maltese: Bħal prodotti mediċinali topiċi oħra, emedastine huwa assorbit fid-demm.
English: Opened:
Maltese: Miftuħ:
English: Belgium.
Maltese: B.
English: Not Known (frequency cannot be estimated from the available data) • General side effects: increased heart rate
Maltese: Mhux magħruf (il-frekwenza ma tistax tiġi stmata mid-dejta disponibbli)
English: Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye).
Maltese: Benzalkonium chloride jista' jikkawża irritazzjoni fl-għajn speċjalment jekk għandek għajnejn xotti jew disturbi fil-kornea (strat ċar quddiem l-għajn).
English: 1 ml of solution contains emedastine 0.5 mg (as difumarate)
Maltese: U KWANTITATTIVA 1 ml ta' soluzzjoni fih 0.5 mg emedastine (bħala difumarate) Eċċipjent b'effett magħruf
English: 0.35 ml x 30 0.35 ml x 60
Maltese: Qtar għall-għajnejn, soluzzjoni 0.35 ml x 30
English: Only use the drops in your eyes.
Maltese: Ma twettaq l-ebda studju ta' interazzjoni.
English: Nervous system disorders Uncommon headache, sinus headache, dysgeusia
Maltese: IL-KONTENUT SKONT IL-PIŻ, IL-VOLUM, JEW PARTI
English: • Throw away any unused containers one week after opening the foil wrapper-even if the containers are still sealed.
Maltese: • Armi l-kontenituri mhux użati ġimgħa wara li tkun ftaħt il-pakkett tal-fojl - anki jekk il kontenituri jkunu għadhom issiġillati.
English: What EMADINE looks like and the contents of the pack EMADINE is a liquid (a solution) supplied in a pack containing a 5 ml or 10 ml plastic (DROP-TAINER) bottle with a screw cap. Not all pack sizes may be marketed.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih EMADINE huwa disponibbli fi flixken opaki tal-plastik tal-għamla DROP-TAINER ta' volum ta' 5 ml u 10 ml.
English: Procysbi is available as gastroresistant capsules (25 and 75 mg).
Maltese: Procysbi huwa disponibbli bħala kapsuli gastro-reżistenti (25 u 75 mg).
English: Procysbi is a ‘hybrid medicine'.
Maltese: Procysbi huwa ‘mediċina ibrida'.
English: Levels were 0.51 nmol/mg with Procysbi, compared with 0.44 nmol/mg with Cystagon.
Maltese: Il-livelli kienu ta' 0.51 nmol/mg b'Procysbi, meta mqabbla ma' 0.44 nmol/mg b'Cystagon.
English: The full EPAR for Procysbi 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 summary of the opinion of the Committee for Orphan Medicinal Products for Procysbi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Other information about Procysbi
Maltese: Informazzjoni oħra dwar Procysbi
English: The most common side effects with Procysbi (which may affect more than 1 in 10 people) are loss of appetite, vomiting, nausea (feeling sick), diarrhoea, lethargy (lack of energy) and pyrexia (fever).
Maltese: L-effetti sekondarji l-aktar komuni b'Procysbi (li jistgħu jolqtu aktar minn 1 minn kull 10) huma nuqqas ta' aptit, rimettar, nawsja (dardir), dijarea, letarġija (nuqqas ta' enerġija) u piressija (deni).
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku mercaptamine
English: This is a summary of the European public assessment report (EPAR) for Procysbi.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Procysbi.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Procysbi on 06.09.2013.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Procysbi fil- 06.09.2013.
English: The active substance in Procysbi, mercaptamine, reacts with cystine to form another amino acid, called cysteine, and a compound called a cysteine-cysteamine salt.
Maltese: Is-sustanza attiva f'Procysbi, mercaptamine, tirreaġixxi maċ-ċistina biex tifforma aċidu amminiku ieħor, magħruf bħala cysteine, u kompost magħruf bħala melħ tas-cysteine-cysteamine.
English: Why is Procysbi approved?
Maltese: Għal xiex ġiet approvat Procysbi?
English: The reference medicine for Procysbi is Cystagon.
Maltese: Il-mediċina ta' referenza għal Procysbi hija Cystagon.
English: This means that it is similar to a ‘reference medicine' containing the same active substance, but Procysbi is available in a formulation that allows for a delayed release of the active substance in the body.
Maltese: Dan ifisser li huwa simili għal ‘mediċina ta' referenza' li fiha l-istess sustanza attiva, imma Procysbi huwa disponibbli f'formulazzjoni li tippermetti rilaxx ittardjat tassustanza attiva fil-ġisem.
English: What are the risks associated with Procysbi?
Maltese: X'inhuma r-riskji assoċjati ma' Procysbi?
English: Because the number of patients with cystinosis is low, the disease is considered ‘rare', and Procysbi was designated an ‘orphan medicine' (a medicine used in rare diseases) on 20 September 2010.
Maltese: Peress li n-numru ta' pazjenti li għandhom iċ-ċistinożi huwa baxx, il-marda hija kkunsidrata ‘rari', u Procysbi ġie kklassifikat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) nhar l20 ta' Settembru 2010.
English: Procysbi is a medicine that contains the active substance mercaptamine (also known as cysteamine).
Maltese: Procysbi huwa mediċina li fiha s-sustanza attiva mercaptamine (magħrufa wkoll bħala ċisteamina).