FrancophonIA/ELRC3.0 huggingface dataset:
English: Reductions in the growth of mean total lesion size, choroidal neovascularisation (CNV size), and fluorescein leak size, have been shown in patients with AMD treated with Macugen.
Maltese: Tnaqqis fit-tkabbir tad-daqs totali medju tal-ferita, neovaskularizzazzjoni choroidal (daqs tal-CNV), u d-daqs tat-tnixxija ta' fluorescein, ġew murija f'pazjenti b'AMD ikkurati b'Macugen.
English: 5.1 Pharmacodynamic properties
Maltese: .1 Proprjetajiet farmakodinamii ċ
English: Immediate (on the day of injection) and delayed intravitreous haemorrhages may occur following pegaptanib injections (see section 4.2).
Maltese: Jistgħu jseħħu emorraġiji immedjati (fil-jum ta' l-injezzjoni) jew aktar tard ġol-vitriji wara injezzjonijiet ta' pegaptanib (ara sezzjoni 4.2).
English: Frequency of these side effects cannot be estimated from the data available.
Maltese: Ma tistax tittieħed stima tal-frekwenza ta' dawn l-effetti sekondarji mid-data disponibbli.
English: • drooping eyelid
Maltese: F'dan il-fuljett
English: Pegaptanib 0.3 mg showed treatment benefit regardless of baseline lesion subtype, lesion size and visual acuity as well as age, gender, iris pigmentation and prior and/or baseline PDT usage.
Maltese: Pegaptanib 0.3 mg wera benefiċċju tal-kura irrispettivament mis-sottotip tal-ferita bażika, id-daqs talferita u l-akutezza viżwali kif ukoll l-eta', is-sess tal-persuna, il-pigmentazzjoni tal-ħabba ta' l-għajn u l-użu preċedenti u/jew bażiku ta' PDT.
English: • injection site reaction, injection site vesicles
Maltese: • reazzjoni fil-post tal-injezzjoni, infafet fil-post tal-injezzjoni
English: Manufacturer:
Maltese: ATTENZJONI:
English: The physician safety brochure should contain the following key elements: a) The intravitreal procedure as it was performed in the pivotal clinical studies, along with any technical improvements b) Use of povidone iodine c) Performing lid scrubs d) Use of anaesthetic to ensure patient comfort e) Sterile techniques to minimize the risk of infection f) Use of antibiotics g) Techniques for the intravitreal injection h) Key signs and symptoms of intravitreal injection related adverse events including endophthalmitis,
Maltese: Il-fuljett fuq is-sigurtà għat-tabib għandu jkun fih l-elementi prinċipali li ġejjin: a) Il-proċedura għal ġol-vitriju kif saret fl-istudji kliniċi pivitali, flimkien ma' kull titjib fit-teknika b) Użu ta' povidone iodine c) Twettiq ta' għarik tal-kappell tal-għajn d) Użu ta' anestetiku biex tiġi żgurata l-kumdità tal-pazjent e) Tekniki sterili biex jitnaqqas ir-riskju ta' infezzjoni f) Użu ta' antibijotiċi g) Tekniki għall-injezzjoni ġol-vitriju h) Sinjali u sintomi prinċipali tal-injezzjoni ġol-vitriju relatati mal-avvenimenti avversi inkluż endophthalmitis, żieda fil-pressjoni fl-għajnejn, ħsara fir-retina, emorraġija fl-għajnejn, kataretti trawmatiċi, ipersensittività u injezzjoni tal-volum żejjed i) Ġestjoni tal-pressjoni fl-għajn (IOP - intraocular pressure) j) Ġestjoni tal-endophthalmitis k) Fehim tal-fatturi ta' riskju involuti fl-iżvilupp tal-endophthalmitis l) Rappurtar ta' episodji avversi serji (nota ta' tfakkir)
English: In animals that received doses of pegaptanib up to 0.5 mg/eye to both eyes, plasma concentrations were 0.03% to 0.15% of those in the vitreous humour.
Maltese: Fl-annimali li rċevew dożi ta' pegaptanib sa 0.5 mg/għajn fiż-żewġ għajnejn, il-konċentrazzjonijiet filplasma kienu 0.03% sa 0.15% ta' dawk fil-likwidu tal-vitriju.
English: • inflammation of the higher respiratory tract, vomiting, indigestion
Maltese: • infjammazzjoni ta l-apparat respiratorju ta' fuq, rimettar, indiġestjoni
English: Uncommon contact dermatitis, eczema, hair colour changes, rash, pruritus, night sweats
Maltese: Mhux komuni dermatite ta' kuntatt, ekżema, bidliet fil-kulur tax-xagħar, raxx, ħakk, tagħriq bil-lejl
English: Adequate anaesthesia and a broad-spectrum topical microbicide should be administered prior to the injection.
Maltese: Qabel l-injezzjoni għandhom jiġu amministrati anestesija xierqa u mikrobiċida topiku bi spettru wiesa'.
English: The patient information should contain the following key elements: m) Key signs and symptoms of serious adverse events associated with the intravitreal injection procedure including endophthalmitis, increased intraocular pressure, retinal injury, intraocular haemorrhage, traumatic cataract, hypersensitivity and injection of excess volume n) When to seek urgent attention from the health care provider
Maltese: L-informazzjoni għall pazjent għandu jkun fiha l-elementi prinċipali li ġejjin: m) Sinjali u sintomi prinċipali ta' episodji avversi serji assoċjati mal-proċedura tal-injezzjoni ġol vitriju inkluż endophthalmitis, żieda fil-pressjoni fl-għajnejn, ħsara fir-retina, emorraġija fl għajnejn, kataretti trawmatiċi, ipersensittività u injezzjoni tal-volum żejjed n) Meta għandu wieħed ifittex attenzjoni urġenti mill-fornitur tal-kura tas-saħħa
English: Intravitreous haemorrhages
Maltese: TAL-PRODOTT MEDI INALI
English: At the end of the first year (week 54), 1053 patients were re-randomized to either continue or discontinue treatment through week 102.
Maltese: Fit-tmiem ta' l-ewwel sena (ġimgħa 54), 1053 pazjent reġgħu ġew magħżula b'mod każwali biex jew ikomplu jew iwaqqfu l-kura sa ġimgħa 102.
English: discontinued
Maltese: Tqala
English: At doses below 0.5 mg/eye, pegaptanib plasma concentrations do not likely exceed 10 ng/ml.
Maltese: F'dożi taħt 0.5 mg/għajn, il-konċentrazzjonijiet ta' pegaptanib filplasma aktarx li ma jaqbżux 10 ng/ml.
English: • elevation of the liver enzymes, abrasion.
Maltese: • żieda fl-enzimi tal-fwied, brix.
English: Macugen is for single use only.
Maltese: Macugen huwa għal użu ta' darba biss.
English: One pre-filled syringe provides a usable amount to deliver a single dose of 90 microlitres containing pegaptanib sodium, corresponding to 0.3 mg of the free acid form of the oligonucleotide.
Maltese: Siringa waħda mimlija bil-lest tipprovdi ammont li jista' jintuża biex tagħti doża waħda ta' 90 mikrolitru li fih pegaptanib sodium, li jikkorrispondi għal 0.3 mg tal-forma ta' aċidu liberu ta' loligonucleotide.
English: How to store Macugen
Maltese: X'fih Macugen:
English: • small marks on the eye surface (punctate keratitis)
Maltese: • marki żgħar fuq is-superfiċje tal-għajn (punctate keratitis),
English: Pegaptanib is metabolised by nucleases and therefore cytochrome P450 mediated drug interactions are unlikely.
Maltese: Pegabtanib jiġi metabolizzat minn enzimi li jikkawżaw l-idrolisi ta' l-aċidi nuklejċi u għalhekk mhumiex probabbli interazzjonijiet ma' mediċini oħra medjati miċ-ċitokromu P450.
English: hypersensitivity and injection of excess volume i) Management of intraocular pressure j) Management of endophthalmitis k) Understanding the risk factors involved in developing endophthalmitis l) Reporting of serious adverse events(reminder aid)
Maltese: Dan jippermetti monitoraġġ kontinwu tal-bilanċ bejn il-benefiċċju u r-riskju tal-prodott mediċinali.
English: • eversion of the eyelid, eye movement disorder, eyelid irritation
Maltese: • qlib tal-kappell tal-għajn, disturb fil-moviment tal-għajn, irritazzjoni fil-kappell tal-għajn
English: CAUTION: Since pre-filled syringe contains more medicinal product volume (250-270 microlitres) than the recommended dose (90 microlitres), a part of the volume contained in the syringe has to be discarded prior to the administration.
Maltese: ATTENZJONI : Peress li s-siringa mimlija bil-lest fiha volum tal-prodott mediċinali aktar (250-270 mikrolitru) mid-doża rakkomandata (90 mikrolitru), parti mill-volum li jkun jinsab fis-siringa għandu jintrema qabel l-amministrazzjoni.
English: Each pack contains a pouch in a carton, containing a pre-filled syringe, Type I glass, filled with 0.250.27 ml of solution, sealed with an elastomeric plunger stopper and a pre-attached plunger rod, held by a plastic clip.
Maltese: Kull pakkett fih borża f'kaxxa li fiha siringa mimlija lesta, tal-ħġieġ tat-Tip 1, mimlija b'0.25-0.27 ml ta' soluzzjoni, issiġillata bi stopper tal-planġer elastomeriku u qasba tal-planġer mwaħħla lesta miżmuma b'molla tal-plastik.
English: Active or suspected ocular or periocular infection.
Maltese: Infezzjonijiet okulari jew periokulari atticivi jew suspettati.
English: Systemic adverse events including non-ocular haemorrhages and arterial thromboembolic events have been reported following intravitreal injection of VEGF inhibitors and there is a theoretical risk that these may relate to VEGF inhibition.
Maltese: Każijiet avversi sistemiċi li jinkludu: emorraġiji (mhux okulari) u avvenimenti tromboemboliċi arterjali, ġew rrappurtati wara injezzjoni ta' inibituri VEGF ġol-vitriju u hemm possibilita' ta' riskju teoretiku li dawn jistgħu jirrelataw ma' inibizzjoni ta' VEGF.
English: • Physician safety brochure
Maltese: Grupp Farmakoterapewtiku:
English: • palpitations, high blood pressure, dilatation of the aorta (the main blood vessel)
Maltese: • palpitazzjonijiet, pressjoni tad-demm għolja, twessigħ tal-aorta (l-arterja prinċipali tad-demm)
English: The syringe has a pre-attached polycarbonate plastic luer lock adaptor and the tip is sealed with an elastomeric tip cap.
Maltese: Is-siringa għandha adapter tal-plastik tal-lukkett luer, u t-tap huwa issiġillat b'kappa elastomerika.
English: The injection procedure should be carried out under aseptic conditions, which includes the use of surgical hand disinfection, sterile gloves, a sterile drape and a sterile eyelid speculum (or equivalent) and the availability of sterile paracentesis (if required).
Maltese: Il-proċedura ta' l-injezzjoni għandha titwettaq taħt kondizzjonijiet asettiċi, li jinkludu l-użu ta' diżinfezzjoni kirurġika ta' l-idejn, ingwanti sterilizzati, ċarruta sterilizzata u speculum sterilizzat għallkappell ta' l-għajn (jew ekwivalenti) u d-disponibilità ta' paracentesis sterilizzat (jekk meħtieġ).
English: Injecting the entire volume of the prefilled syringe could result in overdose (see section 4.8 and 4.9).
Maltese: L-injezzjoni tal-volum kollu tassiringa mimlija bil-lest jista' jirriżulta f'doża eċċessiva (ara sezzjoni 4.8 u 4.9).
English: Reduced body weight (5%) and minimal delayed ossification in forepaw phalanges were observed, only at exposure levels based on AUC of over 300 fold greater than that expected in humans.
Maltese: Kienu osservati tnaqqis fil-piż tal-ġisem (5%) u ossifikazzjoni ttardjata minima fil-falanġi tas-swaba' ta' quddiem, iżda biss f'livelli ta' espożizzjoni bbażati fuq AUC ta' 'l fuq minn 300 darba aktar minn dak mistenni fil-bniedem.
English: Uncommon hypertension, aortic aneurysm
Maltese: Disturbi vaskulari Mhux komuni pressjoni għolja, anewriżma ta' l-aorta
English: Dosing line 3rd Rib (top edge)
Maltese: Fuljett ta' tagħrif:
English: Each pack contains a pouch in a carton containing a 1 ml pre-filled syringe, Type 1 glass, sealed with an elastomeric (brombutyl rubber) plunger stopper and a pre-attached plunger rod, held by a plastic clip.
Maltese: Kull pakkett fih borża f'kaxxa li fiha siringa ta' 1 ml mimlija lesta, tal-ħġieġ tat-Tip 1, issiġillata bi stopper tal-planġer elastomeriku (gomma brombutyl) u qasba tal-planġer mwaħħla lesta miżmuma b'molla tal-plastik.
English: NAME OF THE MEDICINAL PRODUCT Macugen 0.3 mg solution for injection
Maltese: Macugen 0.3 mg soluzzjoni għall-injezzjoni
English: Patients should be instructed to report any symptoms suggestive of these conditions without delay (see section 4.4).
Maltese: Il-pazjenti għandhom jingħataw struzzjonijiet biex jirrapportaw kwalunkwe sintomi li jissuġġerixxu dawn il-kondizzjonijiet mingħajr dewmien (ara sezzjoni 4.4).
English: In mice, rats, rabbits, dogs and monkeys, pegaptanib distributes primarily into plasma volume and is not extensively distributed to peripheral tissues after intravenous administration.
Maltese: Fil-ġrieden, firien, fniek, klieb u xadini, pegaptanib jitqassam prinċipalment ġol-volum tal-plasma u ma jitqassamx b'mod estensiv fit-tessuti periferali wara amministrazzjoni ġol-vitriju.
English: • small lump on your eyelid due to inflammation (chalazion)
Maltese: • nefħa żgħira fuq il-kappell tal-għajn minħabba infjammazzjoni (chalazion)
English: Patients were randomised to receive sham or 0.3 mg, 1 mg or 3 mg pegaptanib administered as intravitreal injections every 6 weeks for 48 weeks.
Maltese: Il-pazjenti ġew magħżula b'mod każwali biex jirċievu sham jew 0.3 mg, 1 mg jew 3 mg pegaptanib mogħti bħala injezzjonijiet ġol-vitriju kull 6 ġimgħat għal 48 ġimgħa.
English: Dose adjustments are not recommended in patients with mild or moderate renal impairment (see section 5.2).
Maltese: Aġġustamenti tad-doża mhumiex rakkomandati f'pazjenti b'indeboliment ħafif jew moderat tal-kliewi (ara sezzjoni 5.2).
English: Treating physician should always expel excess volume of solution according to instructions under the section 6.6.
Maltese: It-tabib li qiegħed jagħti t-trattament għandu dejjem ikeċċi l-volum żejjed ta' soluzzjoni skond l-istruzzjonijiet taħt ittaqsima 6.6.
English: Less frequently reported serious ocular adverse reactions included endophthalmitis, retinal haemorrhage, vitreous haemorrhage and retinal detachment.
Maltese: Każijiet ta' reazzjonijiet allerġiċi serji, inkluż reazzjoni anafilattika u anġjoedema li s-sintomi tagħhom huma deskritti hawn taħt, ġew irrappurtati ftit wara l-injezzjoni.
English: Macugen has not been adequately studied in patients with severe renal impairment.
Maltese: Macugen ma ġiex studjat biżżejjed f'pazjenti b'indeboliment sever tal-kliewi.
English: Warnings and precautions Talk to your doctor before you are given Macugen.
Maltese: Is-sigurtà u l-effikaċja ta' Macugen wara sentejn ma ġietx ippruvata.
English: • night sweats, back pain, tiredness, shivering, tenderness, chest pain, sudden fever and flu-like symptoms (generalised aches and pains)
Maltese: • tagħriq eċċessiv matul il-lejl, uġigħ fid-dahar, għeja, rogħda, sensibilità, uġigħ tas-sider, deni għal għarrieda u sintomi bħal tal-influwenza (weġgħat ġeneralizzati u uġigħ)
English: vitreous floaters and vitreous opacities.
Maltese: Emorraġiji fil-vitriju
English: • disorder of the jelly portion inside the eye (vitreous disorder), such as displacement or tear
Maltese: • disturb tal-porzjon tal-ġelli ġewwa l-għajn (disturb tal-vitriju), bħal spostament jew tiċrit
English: A post marketing observational study has also reported on a small risk of slow sustained increase in intraocular pressure (see section 4.8).
Maltese: Fi studju ta' osservazzjoni wara t-tqegħid tal-prodott fis-suq ġie wkoll irrapurtat riskju żgħir ta' żieda sostnuta bil-mod fil-pressjoni fl-għajnejn (ara sezzjoni 4.8).
English: The majority of adverse reactions reported following administration of Macugen are related to the intravitreal injection procedure.
Maltese: Il-maġġoranza tar-reazzjonijiet avversi rrappurtati wara l-għoti ta' Macugen huma relatati malproċedura tal-injezzjoni ġol-vitriju.
English: Lyophilisate (white lyophilisate)
Maltese: Lyophilisate (lyophilisate abjad)
English: C/ Mocholi 2, Poligono Industrial Mocholi, Noain, 31110 Navarra SPAIN
Maltese: C/ Mocholi 2, Poligono Industrial Mocholi, Noain, 31110 Navarra, SPANJA
English: ATCvet code: QI07AO01
Maltese: QI07AO01
English: 0.5 ml.
Maltese: q.s. 0.5 ml.
English: via Fratelli Cervi snc, Centro Direzionale Milano Due, Palazzo Canova
Maltese: MSD Animal Health S.r.l. via Fratelli Cervi snc, Centro Direzionale Milano Due, Palazzo Canova
English: 1 vial of lyophylisate and 1 vial of solvent (1 dose) 4 vials of lyophylisate and 4 vials of solvent (4 doses) 5 vials of lyophylisate and 5 vials of solvent (5 doses) 10 vials of lyophylisate and 10 vials of solvent (10 doses) 20 vials of lyophylisate and 20 vials of solvent (20 doses) 25 vials of lyophylisate and 25 vials of solvent (25doses) 50 vials of lyophylisate and 50 vials of solvent (50 doses) 100 vials of lyophylisate and 100 vials of solvent (100 doses)
Maltese: 1 kunjett ta' lyophilisate u 1 kunjett ta' solvent (1 doża) 4 kunjetti ta' lyophilisate u 4 kunjetti ta' solvent (4 dożi) 5 kunjetti ta' lyophilisate u 5 kunjetti ta' solvent (5 dożi) 10 kunjetti ta' lyophilisate u 10 kunjetti ta' solvent (10 dożi) 20 kunjett ta' lyophilisate u 20 kunjett ta' solvent (20 doża) 25 kunjett ta' lyophilisate u 25 kunjett ta' solvent (25 doża) 50 kunjett ta' lyophilisate u 50 kunjett ta' solvent (50 doża) 100 kunjett ta' lyophilisate u 100 kunjett ta' solvent (100 doża)
English: Recombinant Protein Q from Leishmania infantum MON-1: ≥ 36.7 ELISA units (EU)* * Antigen content determined in an ELISA against an internal standard.
Maltese: Proteina Q rikombinanti minn Leishmania infantum MON-1: ≥ 36.7 unitajiet ta' ELISA (EU)* * Il-kontenut ta' antiġenu huwa determinat f'ELISA skont standard intern.
English: Overdose (symptoms, emergency procedures, antidotes) if necessary:
Maltese: Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti):
English: Recombinant Protein Q from Leishmania infantum MON-1
Maltese: Proteina Q rikombinanti minn Leishmania infantum MON-1
English: Store in a refrigerator (2 ºC - 8 ºC).
Maltese: Aħżen fil-friġġ (2ºC - 8ºC).
English: To stimulate active immunity against disease caused by Leishmania infantum parasites.
Maltese: Biex tiġi stimulata immunità attiva kontra l-marda kkawżata minn parassiti Leishmania infantum.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports)
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimali li juru effetti mhux mixtieqa) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal) - mhux komuni (aktar minn wieħed iżda inqas minn 10 annimali f'1,000 annimal) - rari (aktar minn wieħed iżda inqas minn 10 annimali f'10,000 annimal) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal, inklużi rapporti iżolati)
English: Per dose of 0.5 ml: Recombinant Protein Q from Leishmania infantum MON-1 ≥ 36.7 EU
Maltese: Għal kull doża ta' 0.5 ml: Proteina Q rikombinanti minn Leishmania infantum MON-1 ≥ 36.7 EU
English: The data has shown that a vaccinated dog has 9.8 times less risk to develop clinical signs, 3.5 times less risk of having detectable parasites and 5 times less risk to develop clinical disease than a non-vaccinated dog.
Maltese: Id-dejta wriet li kelb imlaqqam għandu 9.8 drabi inqas riskju li jiżviluppa sinjali kliniċi, 3.5 drabi inqas riskju li jkollu parassiti intraċċabbli u 5 darbiet inqas riskju li jiżviluppa mard kliniku minn kelb mhux imlaqqam.
English: Date of first authorisation: 20/04/2016
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 20/04/2016
English: Rue Olivier de Serres, Angers Technopole 40971 Beaucouze CEDEX (FRANCE) Tél: + 33 (0) 2 41 22 83 83
Maltese: Rue Olivier de Serres, Angers Technopole 40971 Beaucouze CEDEX (FRANCE)
English: 20 doses
Maltese: 20 doża
English: 4 doses
Maltese: 4 dożi
English: The vaccine is safe in infected dogs.
Maltese: Il-vaċċin huwa sigur fi klieb infettati.
English: Diagnostic tools designed to detect Leishmania antibodies (SLA or IFAT or rk-39 rapid diagnostic tests) should be suitable to enable discrimination between dogs vaccinated with this vaccine and dogs infected with Leishmania infantum.
Maltese: L-għodod dijanjostiċi ddisinjati biex jidentifikaw antikorpi Leishmania (testijiet dijanjostiċi rapidi SLA jew IFAT jew rk-39) għandhom ikunu adattati biex jippermettu diskriminazzjoni bejn il-klieb imlaqqma b'dan il-vaċċin u l-klieb infettati b'Leishmania infantum.
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 talAġenzija Ewropea dwar il-Mediċini (http://www.ema.europa.eu/).
English: Spontaneous resolution of such reaction was observed within 4 hours.
Maltese: Lgħajbien spontanju ta' reazzjoni bħal din ġie osservat fi żmien 4 sigħat.
English: For active immunisation of non-infected dogs from 6 months of age to reduce the risk of developing an active infection and/or clinical disease after exposure to Leishmania infantum.
Maltese: Għall-immunizzazzjoni attiva tal-klieb mhux infettati minn 6 xhur ta' età biex jitnaqqas ir-riskju li jiżviluppaw infezzjoni attiva u/jew mard kliniku wara esponiment għal Leishmania infantum.
English: Plastic box
Maltese: Kaxxa tal-plastik
English: ≥ 36.7 ELISA Units (EU)* * Antigen content determined in an ELISA against an internal standard.
Maltese: (EU)* * Il-kontenut ta' antiġenu huwa determinat f'ELISA skont standard intern.
English: 20090 Segrate (MI) (ITALIA) Tel: + 39 02 516861
Maltese: Tel: + 39 02 516861
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Recombinant Protein Q from L. infantum MON-1
Maltese: ATTIVA(I) Proteina Q rikombinanti minn L. infantum MON-1 KONTENUT BĦALA
English: Each dose of 0.5 ml vaccine contains:
Maltese: Kull doża ta' 0.5 ml tal-vaċċin fiha:
English: White lyophilisate.
Maltese: Aħżen fil-friġġ.
English: Pack sizes:
Maltese: Daqs tal-pakkett:
English: NAME OF THE VETERINARY MEDICINAL PRODUCT LETIFEND lyophilisate for dogs
Maltese: VETERINARJU LETIFEND lyophilisate għall-klieb
English: Laboratorios LETI, S.L.unipersonal C/ Del Sol, 5, Poligono Industrial Norte, Tres Cantos, 28760, Madrid SPAIN
Maltese: Laboratorios LETI, S.L. unipersonal C/ Del Sol, 5, Poligono Industrial Norte, Tres Cantos, 28760, Madrid SPANJA
English: In laboratory studies including experimental challenge with Leishmania infantum, the vaccine reduced the severity of the disease, including clinical signs and parasite burden in spleen and lymph nodes.
Maltese: Fl-istudji kliniċi li jinkudu sfida sperimentali b'Leishmania infantum, il-vaċċin naqqas is-severità talmarda, inkluż is-sinjali kliniċi u l-iskumdità tal-parassiti fil-milsa u l-glandoli limfatiċi.
English: Shelf life of the solvent: 5 years.
Maltese: Żmien kemm idum tajjeb il-solvent: 5 snin.
English: Intervet Hellas AE Αγίου Δημητρίου 63, 174 56 Άλιμος, Αττική, ΕΛΛΆΔΑ Τηλ: +30 210 9897430
Maltese: Τηλ: +30 210 9897430
English: Pharmacotherapeutic group: Immunologicals for Canidae - dog - inactivated parasitic vaccinesleishmania.
Maltese: Sustanzi immunoloġiċi għal Canidae - klieb - vaċċini parasitiċi mhux attivati - leishmania.
English: Solvent Water for injections: q.s.
Maltese: Solvent Ilma għall-injezzjonijiet:
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer of the biological active substance
Maltese: Isem u indirizz tal-manifatturi tas-sustanza bijoloġika attiva
English: NAME OF THE VETERINARY MEDICINAL PRODUCT LETIFEND solvent for dogs
Maltese: VETERINARJU LETIFEND solvent għall-klieb
English: Plastic box containing 25 vials of 1 dose of lyophilisate and 25 vials of 0.8 ml of solvent.
Maltese: Kaxxa tal-plastik li fiha 25 kunjett ta' 1 doża lyophilisate u 25 kunjett ta' 0.8 ml ta' solvent.
English: Plastic box containing 20 vials of 1 dose of lyophilisate and 20 vials of 0.8 ml of solvent.
Maltese: Kaxxa tal-plastik li fiha 20 kunjett ta' 1 doża lyophilisate u 20 kunjett ta' 0.8 ml ta' solvent.
English: Plastic box containing 4 vials of 1 dose of lyophilisate and 4 vials of 0.8 ml of solvent.
Maltese: Kaxxa tal-plastik li fiha 4 kunjetti ta' 1 doża lyophilisate u 4 kunjetti ta' 0.8 ml ta' solvent.
English: Plastic box containing 5 vials of 1 dose of lyophilisate and 5 vials of 0.8 ml of solvent.
Maltese: Kaxxa tal-plastik li fiha 5 kunjetti ta' 1 doża lyophilisate u 5 kunjetti ta' 0.8 ml ta' solvent.