FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP decided that Mycamine's benefits are greater than its risks for the treatment of invasive candidiasis and of oesophageal candidiasis, and for the prophylaxis of Candida infection in patients undergoing allogeneic haematopoietic stem cell transplantation or who are expected to have neutropenia for 10 or more days.
Maltese: Is-CHMP ddeċieda li l-benefiċċji ta' Mycamine huma ikbar mir-riskji tiegħu għat-trattament ta' kandidjażi invażiva u ta' kandidjażi tal-esofogu, u għall-profilassi ta' infezzjoni b'Candida f'pazjenti li jkunu sejrin jagħmlu trapjant alloġeniku ta' ċelluli staminali ematopojetiċi jew li huma mistennija li jkollhom newtropenija għal 10 ijiem jew aktar.
English: Mycamine is also used to treat candidiasis in the oesophagus (gullet) in patients over 16 years of age for whom intravenous treatment is suitable.
Maltese: Mycamine jintuża wkoll biex jittratta kandidjażi fl-esofagu f'pazjenti li għandhom aktar minn 16-il sena li għalihom, trattament intravenuż huwa adatt.
English: Because of a possible risk of liver tumours, Mycamine is only to be used if other antifungal medicines are not appropriate.
Maltese: Minħabba riskju possibbli ta' tumuri fil-fwied, Mycamine għandu jintuża biss jekk mediċini oħra antifungali ma jkunux xierqa.
English: How does Mycamine work?
Maltese: Għalxiex jintuża Mycamine?
English: The effectiveness of Mycamine has been studied in four main studies, in which it was compared with other antifungal medicines.
Maltese: L-effikaċja ta' Mycamine ġiet studjata f'erba' studji prinċipali, li fihom tqabbel ma' mediċini antifungali oħrajn.
English: EU/1/18/1310/001
Maltese: EU/1/18/1310/001 Deferiprone Lipomed
English: Blister (aluminium/PVC/PVDC)
Maltese: Folja (alu/PVC/PVDC) 100 pillola
English: 500 mg Film-coated tablet
Maltese: 500 mg Pillola miksija b'rita Użu orali
English: Deferiprone Lipomed
Maltese: Mnejn għandu jingħata
English: 2 tubes 12 tubes 20 tubes 40 tubes
Maltese: 2 tubi 12 tubi 20 tubi 40 tubi
English: EU/2/14/170/0001 (2 tubes) EU/2/14/170/0002 (12 tubes) EU/2/14/170/0003 (20 tubes) EU/2/14/170/0004 (40 tubes)
Maltese: EU/2/14/170/0001 (2 tubi) EU/2/14/170/0002 (12-il tubu) EU/2/14/170/0003 (20 tubu) EU/2/14/170/0004
English: Excipient: Butylhydroxytoluene (E321):
Maltese: Butylhydroxytoluene (E321):
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (1.2 g) contains:
Maltese: U KWANTITATTIVA Doża (1.2 g) fiha:
English: Elanco France S.A.S., 26 Rue de la Chapelle, 68330 Huningue, France
Maltese: Elanco France S.A.S., 26 Rue de la Chapelle, 68330 Huningue, Franza
English: Its spectrum of activity includes Gram-positive and Gram-negative bacteria including Staphylococcus pseudintermedius (MIC90 of 8 µg/ml).
Maltese: L-ispettru ta' attività tiegħu jinkludi batterji Gram-pożittivi u Gram-negattivi inkluż Staphylococcus pseudintermedius (MIC90 ta' 8 µg/ml).
English: Betamethasone is known to be teratogenic in laboratory species.
Maltese: Betamethasone huwa magħruf li huwa teratoġeniku fi speċijiet tal-laboratorju.
English: Argenta Dundee Limited, Kinnoull Road, Dunsinane Industrial Estate, Dundee DD2 3XR, UNITED KINGDOM
Maltese: Argenta Dundee Limited, Kinnoull Road, Dunsinane Industrial Estate, Dundee DD2 3XR, IR-RENJU UNIT
English: 1 mg equivalent to Betamethasone base 0.9 mg
Maltese: 1 mg ekwivalenti għal bażi ta' Betamethasone 0.9 mg
English: 5.2 Pharmacokinetic particulars
Maltese: 5.2 Tagħrif farmakokinetiku
English: 1 mg For the full list of excipients, see section 6.1.
Maltese: 1 mg Għal-lista sħiħa tal-ingredjenti mhux attivi, ara s-sezzjoni 6.1.
English: Terbinafine is an allylamine with a pronounced fungicidal activity.
Maltese: Terbinafine huwa allylamine b'attività fungiċida pronunzjata.
English: For animal treatment only.
Maltese: prodotti mediċinali veterinarji.
English: The veterinary medicinal product is a fixed combination of three active substances (corticosteroid, antifungal and antibiotic):
Maltese: Il-prodott mediċinali veterinarju huwa kombinazzjoni fissa ta' tliet sustanzi attivi (kortikosterojde, antifungali u antibijotiku):
English: Cardboard box containing 2, 12, 20 or 40 tubes (each tube containing 2.05 g of product of which a single dose of 1.2 g can be extracted).
Maltese: Kaxxa tal-kartun li fiha 2, 12, 20 jew 40 tubu (kull tubu fih 2.05 g ta' prodott li minnu tista' tiġi estratta doża waħda ta' 1.2 g).
English: Pharmacotherapeutic group: Otologicals - Corticosteroids and anti-infectives in combination.
Maltese: Otoloġiċi - Kortikosterojdi u anti-infettivi flimkien.
English: The veterinary medicinal product may be irritating to eyes.
Maltese: Il-prodott mediċinali veterinarju jista' jkun irritanti għall-għajnejn.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Auricular use
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI Użu awrikulari
English: The decreased adrenal and thymus weights accompanied by atrophy of the adrenal cortex and lymphoid depletion of the thymus correlated with the decreased cortisol levels, and were consistent with the pharmacologic effects of betamethasone.
Maltese: It-tnaqqis fil-piżijiet adrenali u tattimu flimkien ma' atrofija tal-kortiċi adrenali u tnaqqis fil-limfojdi tat-timu kienu korrelatati mattnaqqis fil-livelli ta' kortisol, u kienu konsistenti mal-effetti farmakoloġiċi ta' betamethasone.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) One dose (1.2 g) contains 10 mg terbinafine, 10 mg florfenicol and 1 mg betamethasone acetate Excipient: 1 mg butylhydroxytoluene (E 321)
Maltese: Doża wieħed (1.2 g) fih 10 mg terbinafine, 10 mg florfenicol u 1 mg betamethasone acetate Sustanza mhux attiva: 1 mg butylhydroxytoluene (E 321)
English: Do not use during pregnancy and lactation (see section 4.3).
Maltese: Tużax waqt tqala u treddigħ (ara s-sezzjoni 4.3).
English: MANUFACTURER'S BATCH NUMBER Lot
Maltese: NUMRU TAL-LOTT TAL-MANIFATTUR LOTT
English: NAME OF THE VETERINARY MEDICINAL PRODUCT OSURNIA ear gel for dogs terbinafine/florfenicol/betamethasone acetate
Maltese: VETERINARJU OSURNIA ġel għall-widnejn għall-klieb terbinafine/florfenicol/betamethasone acetate
English: Additionally, dogs showed slightly elevated red blood cell count, hematocrit, total protein, albumin and alanine aminotransferase.
Maltese: Barra minn hekk, il-klieb urew għadd ta' ċelluli tad demm ħomor, ħematokrit, proteina totali, albumina u alanina aminotransferase kemxejn għoljin.
English: Prolonged and intensive use of topical corticosteroids preparation is known to trigger systemic effects, including suppression of adrenal function (see section 4.10).
Maltese: Użu fit-tul u intensiv ta' preparazzjoni ta' kortikosterojdi topiċi huwa magħruf li jqanqal effetti sistemiċi, inkluż trażżin tal-funzjoni adrenali (ara s-sezzjoni 4.10).
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) 10 mg terbinafine, 10 mg florfenicol, 1 mg betamethasone acetate
Maltese: ATTIVA(I) 10 mg terbinafine, 10 mg florfenicol, 1 mg betamethasone acetate
English: STATEMENT OF ACTIVE SUBSTANCES 1 dose: 10 mg terbinafine, 10 mg florfenicol, 1 mg betamethasone acetate
Maltese: 1 doża: 10 mg terbinafine, 10 mg florfenicol, 1 mg betamethasone acetate
English: Administer one tube per infected ear.
Maltese: Agħti tubu wieħed lil kull widna infettata.
English: CLINICAL PARTICULARS
Maltese: suċċess kliniku.
English: There were no clinical signs associated with unilateral vesicle formation within the epithelium of the tympanic membrane (also observed after six administrations, one week apart, of 1 tube per ear or 2 tubes per dog), unilateral mucosal ulceration in the lining of the middle ear cavity, or decrease in serum cortisol response below normal reference range in ACTH stimulation testing.
Maltese: Ma kien hemm ebda sinjal kliniku assoċjat mal-formazzjoni ta' nuffata unilaterali fl-epitelju tal-membrana timpanika (osservati wkoll wara sitt għotjiet, ġimgħa bejn waħda u oħra, ta' tubu għal kull widna jew 2 tubi għal kull kelb), ulċerazzjoni mukosali unilaterali fl-inforra tan-nofs tal-widna, jew tnaqqis fir-rispons ta' kortisol fis-serum taħt ilmedda ta' referenza normali fl-ittestjar tal-istimulazzjoni ACTH.
English: Auricular use.
Maltese: Mhux applikabbli.
English: Systemic absorption of all active substances was determined in multiple-dose studies after placing the veterinary medicinal product into both ear canals of healthy mixed breed dogs.
Maltese: Assorbiment sistemiku tas-sustanzi attivi kollha kien determinat fi studji b'dożi multipli wara ttqegħid tal-prodott mediċinali veterinarju fiż-żewġ kanali tal-widnejn ta' klieb ta' razza mħallta f'saħħithom.
English: OSURNIA ear gel for dogs is available in the following pack sizes: 1 cardboard box containing 2 tubes, 1 cardboard box containing 12 tubes 1 cardboard box containing 20 tubes 1 cardboard box containing 40 tubes Not all pack sizes may be marketed.
Maltese: OSURNIA ġel għall-widnejn għall-klieb huwa disponibbli fid-daqsijiet ta' pakketti li ġejjin: kaxxa tal-kartun waħda li fiha 2 tubi, kaxxa tal-kartun waħda li fiha 12-il tubu kaxxa tal-kartun waħda li fiha 20 tubu kaxxa tal-kartun waħda li fiha 40 tubu
English: Do not use in dogs with generalised demodicosis (demodectic mange).
Maltese: Tużax fil-klieb b'demodicosis ġeneralizzata (mange demodettika).
English: 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 tal-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu/.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT OSURNIA ear gel for dogs terbinafine, florfenicol, betamethasone acetate (EN or Latin)
Maltese: VETERINARJU OSURNIA ġel għall-widnejn għall-klieb terbinafine, florfenicol, betamethasone acetate (EN)
English: ROUTE(S) OF ADMINISTRATION Auricular use
Maltese: MOD(I) TA' AMMINISTRAZZJONI
English: Terbinafine has a different mode of action than azole antifungals, therefore there is no cross resistance with azole antifungals.
Maltese: Terbinafine għandu azzjoni differenti minn antifungali ta' azole, għalhekk m'hemm ebda reżistenza inkroċjata ma' antifungali azole.
English: Auricular administration of five times the recommended dose, one week apart, for 5 consecutive weeks (a total six administrations of 5 tubes per ear or 10 tubes per dog) to mixed breed dogs weighing 10 to 14 kg resulted in clinical signs of wetness of the inner and outer pinna (attributed to presence of the product).
Maltese: L-għoti awrikolari ta' ħames darbiet id-doża rakkomandata, b'intervall ta' ġimgħa bejn waħda u loħra, għal 5 ġimgħat konsekuttivi (total ta' sitt għotjiet ta' 5 tubi għal kull widna jew 10 tubi għal kull kelb) lil klieb ta' razza mħallta li jiżnu 10 sa 14-il kg irriżulta f'sinjali kliniċi ta' tixrib tal-pinna ta' ġewwa u ta' barra (attribwit għall-preżenza tal-prodott).
English: It selectively inhibits the early synthesis of ergosterol, which is an essential component of the membrane of yeasts and fungi including Malassezia pachydermatis (MIC90 of 2 µg/ml).
Maltese: Huwa jinibixxi b'mod selettiv is-sintesi bikrija ta' ergosterol, li huwa komponent essenzjali tal-membrana ta' ħmira u fungi inkluż Malassezia pakidermatite (MIC90 ta' 2 µg/ml).
English: Prolonged and intensive use of topical corticosteroids preparation is known to trigger systemic effects, including suppression of adrenal function.
Maltese: Użu fit-tul u intensiv ta' preparazzjoni ta' kortikosterojdi topiċi huwa magħruf li jqanqal effetti sistemiċi, inkluż trażżin tal-funzjoni adrenali.
English: Prolonged and intensive use of topical corticosteroids preparation is known to trigger systemic effects, including suppression of adrenal function (see section Overdose).
Maltese: Użu fit-tul u intensiv ta' preparazzjoni ta' kortikosterojdi topiċi huwa magħruf li jqanqal effetti sistemiċi, inkluż trażżin tal-funzjoni adrenali (ara s-sezzjoni Doża eċċessiva).
English: Repeat the administration after 7 days.
Maltese: Irrepeti l-għoti wara 7 ijiem.
English: Single-use multi-layered aluminium and polyethylene tube with a polypropylene thermoplastic elastomer tip.
Maltese: In-natura u l-għamla tal-ippakkjar li jmiss mal-prodott Tubu tal-polyethylene u l-aluminju b'ħafna saffi għall-użu ta' darba b'tarf tal-elastomer termoplastiku talpolypropylene.
English: Marketing authorisation holder: Elanco GmbH, Heinz-Lohmann-Str. 4, 27472 Cuxhaven, Germany
Maltese: 4, 27472 Cuxhaven, Il-Ġermanja
English: The extent of percutaneous absorption of topical medications is determined by many factors including the integrity of the epidermal barrier.
Maltese: Il-grad ta' assorbiment perkutaneju ta' medikazzjonijiet topiċi huwa determinat minn ħafna fatturi li jinkludu l-integrità tal-barriera epidermali.
English: Introduce this flexible soft tip into the ear canal.
Maltese: Daħħal din il-ponta ratba flessibbli fil-kanal tal-widna.
English: ATC-vet code: QS02CA90.
Maltese: QS02CA90. 5.1 Kwalitajiet farmakodinamiċi
English: Absorption occurred primarily during the first two to four days after administration, with low plasma concentrations (1 to 42 ng/ml) of active substances.
Maltese: L-assorbiment seħħ primarjament matul l-ewwel 2-4 ijiem wara l-għoti, b'konċentrazzjonijiet fil-plażma baxxi (1 sa 42 ng/ml) ta' sustanzi attivi.
English: Reversibility of the epithelial tympanic membrane blistering is also likely through epithelial migration, a natural self-cleaning and self-repair mechanism for the tympanic membrane and ear canal.
Maltese: Ir-riversibilità tal-infafet fil-membrana timpanika epiteljali hija probabbli wkoll permezz ta' migrazzjoni epiteljali, mekkaniżmu naturali ta' awto-tindif u awto-tiswija għall-membrana timpanika u l-kanal tal-widna.
English: Treatment of acute otitis externa and acute exacerbation of recurrent otitis externa associated with Staphylococcus pseudintermedius and Malassezia pachydermatis.
Maltese: Kura ta' otite esterna akuta u taħrix akut ta' otite rikorrenti esterna assoċjata ma' Staphylococcus pseudintermedius u Malassezia pachydermatis.
English: Florfenicol is a bacteriostatic antibiotic which acts by inhibiting protein synthesis.
Maltese: Florfenicol huwa antibijotiku batterjostatiku li jaħdem billi jinibixxi s-sinteżi tal-proteini.
English: The formulation dissolves in ear wax and is slowly eliminated from the ear mechanically.
Maltese: Il-formulazzjoni tinħall fix-xama' tal-widna u hija eliminata bil-mod mill-widna mekkanikament.
English: Additional corticosteroid treatments should be avoided.
Maltese: antifungali u kortikosterojde.
English: Elanco France S.A.S.
Maltese: Elanco GmbH Heinz-Lohmann-Str.
English: United Kingdom
Maltese: TAMMINISTRA
English: Decreased cortisol levels were observed after product instillation in tolerance studies (before and after ACTH stimulation), indicating that betamethasone is absorbed and enters the systemic circulation.
Maltese: Livelli ta' kortisol imnaqqsa ġew osservati wara l-instillazzjoni tal-prodott fi studji ta' tolleranza (qabel u wara stimulazzjoni tal-ACTH).
English: EXPIRY DATE EXP
Maltese: PARIR SABIEX
English: Use with precaution in dogs with suspected or confirmed endocrine disorder (i.e. diabetes mellitus; hypo- or hyper-thyroid disease, etc.).
Maltese: Uża bi prekawzjoni fi klieb b'disturb endokrinali suspettat jew ikkonfermat (jiġifieri dijabete mellitus;
English: PACKAGE LEAFLET: OSURNIA ear gel for dogs
Maltese: 13. PREKAWZJONIJIET SPEĊJALI DWAR RIMI
English: Due to the high antimicrobial concentrations achieved in the ear canal and the multifactorial nature of otitis externa, in vitro susceptibility may not be directly correlated with clinical success.
Maltese: Minħabba l-konċentrazzjonijiet antimikrobiċi għoljin miksubin fil-kanal tal-widna u n-natura multifattorjali tal-otite esterna, is-suxxettibilità in vitro jaf ma tkunx korrelatata direttament ma'
English: In case of accidental ocular exposure, flush the eyes thoroughly with water for 10 to 15 minutes.
Maltese: F'każ ta' esponiment okulari aċċidentali, laħlaħ l-għajnejn tajjeb bl-ilma għal bejn 10 sa 15-il minuta.
English: After application, the base of the ear may be massaged briefly and gently to facilitate even distribution of the veterinary medicinal product into the ear canal.
Maltese: Wara l-applikazzjoni, il-parti tal-widna tista' tiġi mmassaġġjata għal qasir żmien u ġentilment sabiex tiffaċilita distribuzzjoni uniformi tal-prodott mediċinali veterinarja fil-kanal tal-widna.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT OSURNIA ear gel for dogs
Maltese: VETERINARJU OSURNIA ġel għall-widnejn għall-klieb
English: In case of accidental ingestion by humans, seek medical advice immediately and show the package leaflet or the label to the physician.
Maltese: F'każ li jkun hemm inġestjoni aċċidentali minn persuni umani, fittex parir mediku immedjatament u uri l-fuljett tal-imballaġġ jew it-tikketta lit-tabib.
English: PHARMACEUTICAL FORM Ear gel
Maltese: GĦAMLA FARMAĊEWTIKA Ġel għall-widnejn
English: Transient wetness of the inner and outer pinna can be observed.
Maltese: Ġie osservat tixrib temporanju tal-pinna ta' ġewwa u ta' barra.
English: TARGET SPECIES
Maltese: Użu awrikulari
English: The safety of the product has not been established in dogs less than 2 months of age and weighing less than 1.4 kg.
Maltese: Is-sigurtà tal-prodott ma ġietx ittestjata fi klieb li għandhom inqas minn xahrejn jew li jiżnu inqas minn 1.4 kg.
English: Betamethasone acetate belongs to the diesters class of the glucocorticosteroids with a potent intrinsic glucocorticoid activity which relieves both inflammation and pruritus leading to an improvement of clinical signs observed in otitis externa.
Maltese: glukokortikojde intrinsika qawwija li ttaffi kemm infjammazzjoni kif ukoll ħakk li jwassal għal titjib fis-sinjali kliniċi osservati fl-otite esterna.
English: EU/1/14/987/001 Holoclar cells/cm²
Maltese: EU/1/14/987/001 Holoclar ċelluli/cm2
English: Living tissue equivalent
Maltese: Ekwivalenti għal tessut ħaj
English: 1 implant
Maltese: Bħala impjant
English: Screw cap container (stainless steel)
Maltese: Kontenitur b'għatu bil-kamin (azzar li ma jissaddadx)
English: Implantation
Maltese: Impjant wieħed
English: EMA/HMPC/432131/2013
Maltese: Ġewż EMA/HMPC/432131/2013
English: The HMPC also noted studies in laboratory tests, which showed that walnut leaf has antimicrobial effects.
Maltese: L-HMPC innota wkoll studji f'testijiet tal-laboratorji, li wrew li l-ġewż għandu effetti antimikrobiċi.
English: This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Maltese: Dan ifisser li, għalkemm hemm nuqqas ta' evidenza minn provi kliniċi, l-effikaċja ta' dawn il-mediċini erbali hija plawżibli u hemm evidenza li ntużaw b'mod sigur b'dan il-mod għal ta' lanqas 30 sena (inkluż għallinqas 15-il sena flUE).
English: If symptoms persist, a doctor should be consulted.
Maltese: Jekk is-sintomi jippersistu, għandu jiġi kkonsultat tabib.
English: How are walnut leaf medicines approved in the EU?
Maltese: Kif jiġu approvati l-mediċini bil-ġewż fl-UE?
English: Walnut leaf
Maltese: Ġewż
English: Other information about walnut leaf medicines
Maltese: Aktar informazzjoni dwar il-mediċini bil-ġewż
English: What is walnut leaf?
Maltese: X'inhu l-ġewż?
English: Herbal medicines containing walnut leaf are usually available as comminuted herbal material to be boiled in water to make a ‘decoction' which is applied to the skin.
Maltese: Mediċini erbali li fihom il-ġewż huma normalment disponibbli bħala materjal erbali f'biċċiet żgħar biex jitgħalla fl-ilma biex issir ‘dekozzjoni' li tiġi applikata fuq il-ġilda.
English: What are the risks associated with walnut leaf medicines?
Maltese: X'inhuma r-riskji assoċjati mal-mediċini bil-ġewż?
English: Further information on the HMPC assessment of walnut leaf medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of walnut leaf.
Maltese: Dan id-dokument huwa sommarju tal-konklużjonijiet xjentifiċi li wasal għalihom il-Kumitat għallProdotti Mediċinali Erbali (HMPC) dwar l-użu mediċinali tal-ġewż.
English: In its assessment the HMPC considered the potential effects of juglone (a toxic component of walnut tree) but noted that it is only present in traces (very small amounts) in dry walnut leaf and therefore does not pose a risk to human health.
Maltese: Filvalutazzjoni tiegħu, l-HMPC ikkunsidra l-effetti potenzjali ta' juglone (komponent tossiku tas-siġra talġewż) iżda nnota li huwa preżenti biss fi traċċi (ammonti żgħar ħafna) fil-ġewż niexef u għalhekk ma joħloqx riskju għas-saħħa tal-bniedem.
English: Further information on the risks associated with walnut leaf medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: Aktar informazzjoni dwar ir-riskji assoċjati mal-mediċini bil-ġewż, inklużi l-prekawzjonijiet xierqa għallużu sigur tagħhom, tinsab fil-monografu taħt it-tab ‘Id-dokumenti kollha' fis-sit elettroniku talAġenzija:
English: Moreover, the intended use does not require medical supervision.
Maltese: Barra minn hekk, l-użu intenzjonat ma għandux bżonn superviżjoni medika.
English: Any applications for the licensing of medicines containing walnut leaf have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Maltese: Kwalunkwe applikazzjoni għal-liċenzjar ta' mediċini li fihom il-ġewż għandha tiġi ppreżentata lillawtoritajiet nazzjonali responsabbli mill-prodotti mediċinali li jivvalutaw l-applikazzjoni għall-mediċina erbali u jqisu l-konklużjonijiet xjentifiċi tal-HMPC.
English: What evidence supports the use of walnut leaf medicines?
Maltese: X'evidenza tappoġġa l-użu tal-mediċini bil-ġewż?
English: Walnut leaf is the common name for the whole leaf of the tree Juglans regia L. The leaf is gathered from wild or cultivated trees.
Maltese: L-informazzjoni dwar l-użu u l-liċenzjar tal-mediċini bil-ġewż fl-Istati Membri tal-UE għandha tinkiseb mill-awtoritajiet nazzjonali rilevanti.
English: ATCvet code: QI09AA03.
Maltese: QI09AA03.
English: Sodium chloride solution (0.9%)
Maltese: Soluzzjoni tal-klorur tas-sodju (0.9%)
English: 25 ml (25 doses) 50 ml (50 doses)
Maltese: 25 ml (25 doża) 50 ml (50 doża)
English: IDT Biologika GmbH Am Pharmapark 06861 Dessau-Rosslau GERMANY
Maltese: Pharmapark 06861 Dessau-Rosslau
English: FLUAV/Hamburg/NY1580/2009(H1N1)pdm09 (human origin), FLUAV/swine/Schallern/IDT19989/2014 (H1N1)pdm09 (swine origin) and FLUAV/sw/Teo(Spain)/AR641/2016 (H1N1)pdm09 (swine origin).
Maltese: FLUAV/Hamburg/NY1580/2009(H1N1)pdm09 (oriġini umana), FLUAV/swine/Schallern/IDT19989/2014 (H1N1)pdm09 (oriġini tal-majjali) u FLUAV/sw/Teo(Spanja)/AR641/2016 (H1N1)pdm09 (oriġini tal-majjali).
English: Date of first authorisation: 17/05/2017
Maltese: Data tal-ewwel awtorizzazzjoni: 17/05/2017
English: Store in a refrigerator (2 ºC−8 ºC).
Maltese: Aħżen fil-friġġ (2 ºC−8 ºC).
English: EU/2/17/209/001 (25 doses) EU/2/17/209/002 (50 doses)
Maltese: EU/2/17/209/001 (25 doża)
English: PET vials:
Maltese: Kunjett PET: