FrancophonIA/ELRC3.0 huggingface dataset:
English: What is the risk associated with Bovela?
Maltese: X'riskji huma assoċjati ma' Bovela?
English: In the laboratory studies Bovela prevented PI in 100% of calves while the animals that received no vaccination gave birth to 100% PI calves.
Maltese: Fl-istudji tal-laboratorju, Bovela impedixxa PI f'100% tal-għoġġiela filwaqt li l-annimali li ma rċevew ebda tilqima welldu għoġġiela 100% PI.
English: The most common side effect (seen in more than 1 in 100 cattle) was an increase in body temperature (within the normal range) within four hours of vaccination, which spontaneously resolves within 24 hours.
Maltese: L-aktar effett sekondarju komuni (li deher f'aktar minn fart 1 minn kull 100) kien żieda fit-temperatura tal-ġisem (fi ħdan il-medda normali) fi żmien erba' sigħat mit-tilqima, li titlaq spontanjament fi żmien 24 siegħa.
English: What is the withdrawal period?
Maltese: Liema benefiċċju wera Bovela waqt l-istudji li twettqu?
English: In pregnant cows, BVD infection can cause abortions or result in the birth of calves that are persistently infected (PI).
Maltese: F'baqar tqal, infezzjoni b'BVD tista' tikkawża abort jew tirriżulta fit-twelid ta' għoġġiela li huma infettati persistentament (PI).
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Bovela on 22 December 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea għal Bovela fi 22/12/2014.
English: It is available as a lyophilisate (freeze dried powder) and solvent for injection.
Maltese: Huwa disponibbli bħala lijofilisat (trab imnixxef bil-friża) u solvent għal injezzjoni.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Bovela exceed the risks for the approved indication and recommended that Bovela be given a marketing authorisation.
Maltese: Il-Kumitat għal Prodotti Mediċinali għal Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' Bovela jisbqu r-riskji għall-indikazzjoni approvata u rrakkomanda li Bovela jingħata awtorizzazzjoni għattqegħid fis-suq.
English: What is Bovela?
Maltese: X'inhu Bovela?
English: PI animals tend never to reach their productive potential, have reduced fertility and are more susceptible to other diseases.
Maltese: Annimali PI għandhom it-tendenza li qatt ma jilħqu lpotenzjal produttiv tagħhom, ikollhom fertilità mnaqqsa u jkunu aktar suxxettibbli għal mard ieħor.
English: How has Bovela been studied?
Maltese: Kif ġie studjat Bovela?
English: The main measure of effectiveness was the reduction in the number of persistently infected newborn calves as determined by virus specific identification tests.
Maltese: Il-miżura ewlenija tal-effikaċja kienet it-tnaqqis fin-numru ta' għoġġiela tat-twelid infettati b'mod persistenti kif stabbilit mit-testijiet ta' identifikazzjoni speċifika għalll-virus.
English: Bovela is used to protect cattle against BVD viral infection.
Maltese: Dan jgħin biex jipproteġi lill-frat kontra infezzjonijiet tal-BVD.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Maltese: Vaċċini jaħdmu billi "jgħallmu" lis-sistema immuni (id-difiżi naturali tal-ġisem) kif tiddefendi ruħha kontra marda.
English: The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Maltese: Il-bilanċ benefiċċju-riskju jista' jinstab fil-modulu tad-diskussjoni xjentifika ta' dan lEPAR.
English: They may progress to have mucosal disease which is another form of BVD disease with ulcers and blisters on the snout and inside of the mouth.
Maltese: Jistgħu javvanzaw sabiex ikollhom marda mukosali li hija forma oħra ta' marda BVD b'ulċeri u nuffati fuq l-imnieħer u ġewwa l-ħalq.
English: How does Bovela work?
Maltese: Għaliex ġie appruvat Bovela?
English: When Bovela is given to cattle the animals' immune system recognises the virus strains as ‘foreign' and makes antibodies against them.
Maltese: Meta Bovela jingħata lillfrat, is-sistema immuni tal-annimali tagħraf ir-razez tal-virus bħala "barranin" u tagħmel antikorpi kontrihom.
English: Date of latest renewal: 19 March 2009
Maltese: Data tal-aħħar tiġdid: 19 ta' Marzu 2009
English: Rash, Erythema2
Maltese: Raxx, Eritema2
English: EU/1/99/101/001
Maltese: FIS-SUQ EU/1/99/101/001
English: Pharmacotherapeutic group: Preparation for treatment of wounds and ulcers, ATC code: D 03 AX06
Maltese: Preparazzjoni għal trattament ta' feriti u ulċeri, Kodiċi ATC: D 03 AX06
English: Janssen-Pharmaceutica N.V., Turnhoutseweg 30, B-2340 Beerse, Belgium.
Maltese: Janssen-Pharmaceutica N.V., Turnhoutseweg 30, B-2340 Beerse, Il-Belġju
English: Each gram of Regranex contains 100 micrograms of becaplermin.
Maltese: Kull gramma ta' REGRANEX fiha 100 mikrogramma ta' becaplermin.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 29 March 1999
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TA' L-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni : 29 ta'Marzu 1999
English: OUTER BOX/TUBE
Maltese: KAXXA TA' BARRA/TUBU
English: - Care should be taken during use to avoid microbial contamination and spoilage.
Maltese: - Għandu jkun hemm attenzjoni waqt l-użu biex tiġi evitata kontaminazzjoni bil-mikrobi u taħsir.
English: Dermatitis bullous, Excessive granulation tissue
Maltese: Dermatite bulluża, Tessut ta' granulazzjoni eċċessiv
English: Novartis Pharmaceuticals Corporation (Novartis NPC)., 2010 Cessna Drive, Vacaville, CA 95688, USA.
Maltese: Cessna Drive, Vacaville, CA 95688, USA
English: Tel: +33 1 55 00 22 00 Info. Méd.
Maltese: Tel: +33 1 55 00 22 00 Info.
English: For a full list of excipients, see section 6.1.
Maltese: Għall-lista kompleta ta' sustanzi mhux attivi, ara sezzjoni 6.1.
English: Luxembourg/Luxemburg JANSSEN-CILAG N.V./S.A.
Maltese: Luxembourg/Luxemburg JANSSEN-CILAG N.V./S.
English: Belgique/Belgien Tel: +32 3 280 54 11
Maltese: A. Belgique/Belgien Tel: +32 3 280 54 11
English: Burning sensation1
Maltese: Sensazzjoni ta' ħruq1
English: REGRANEX 0.01% gel becaplermin
Maltese: REGRANEX 0.01% ġell becaplermin
English: INFORMATION IN BRAILLE (CARTON ONLY) REGRANEX
Maltese: INFORMAZZJONI BIL-BRAILLE (IL-KARTUNA BISS) REGRANEX
English: Adverse Drug Reactions Frequency Category Common (≥1/100 to <1/10)
Maltese: Reazzjonijiet Avversi għall-Mediċina Kategorija ta' Frekwenza Komuni (≥1/100 sa <1/10)
English: Gel in a multidose tube (15 gram).
Maltese: Ġell f'tubu ta' dożi multipli (15-il gramma).
English: REGRANEX 0.01% Gel.
Maltese: REGRANEX 0.01% ġell
English: The safety of REGRANEX Gel was evaluated in 1883 adult patients who participated in 17 clinical trials of REGRANEX and placebo and/or standard therapy (saline dressing).
Maltese: Is-sigurtà tal-Ġell REGRANEX ġiet stmata f'1883 pazjent adult li pparteċipaw fi 17-il prova klinika ta' REGRANEX u plaċebo u/jew kura standard (garza bis-saline).
English: • Infected skin ulcer (very common)
Maltese: • Ulċera infettata fil-ġilda (komuni ħafna)
English: The displayed frequency categories use 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); not known (cannot be estimated from the available clinical trial data).
Maltese: Il-kategoriji ta' frekwenza murija jużaw il-konvenzjoni li ġejja : komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1000 sa <1/100); rari (≥1/10,000 to <1/1000); rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid- dejtà min provi kliniċi disponibbli).
English: * Recombinant human Platelet Derived Growth Factor-BB (rhPDGF-BB) produced in Saccharomyces cerevisiae by recombinant DNA technology.
Maltese: *Fattur tat-Tkabbir Derivat mill-Platelet uman rikombinanti - BB (rhPDGF-BB) prodott ġo Saccharomyces cerevisiae bit-teknoloġija tad-DNA rikombinanti.
English: There are no known incompatibilities.
Maltese: M'hemmx inkompatibilitajiet magħrufa.
English: REGRANEX contains E218 (methyl parahydroxybenzoate) and E216 (propyl parahydroxybenzoate).
Maltese: Regranex fih E218 (methyl parahydroxybenzoate) u E216 (propyl parahydroxybenzoate).
English: • If your ulcer is infected
Maltese: • Jekk l-ulċera tiegħek hija infettata
English: From data combined from 4 clinical trials conducted over a 20 week treatment phase for ulcers of baseline surface area less than or equal to 5 cm2, 47% of ulcers treated with becaplermin 100 μg/g gel completely healed, compared to 35% which were treated with placebo gel alone.
Maltese: Minn informazzjoni kkombinata minn 4 provi kliniċi magħmula fuq fażi ta' trattament ta' 20 ġimgħa għal ulċeri ta' linja bażi ta' erja superfiċjali ta' inqas minn jew daqs 5ċm2 , 47% tal ulċeri trattati b'becaplermin 100μg/g ġell fiequ kompletament, ipparagunati ma' 35% li ġew trattati b'ġell plaċebo waħdu.
English: Based on pooled safety data from these clinical trials, the most commonly reported (≥5% incidence) adverse drug reactions (ADRs) were (with % incidence) infected skin ulcer (12.3), cellulitis (10.3), and osteomyelitis (7.2).
Maltese: Fuq bażi ta' dejtà pooled ta' sigurtà minn dawn il-provi kliniċi, l-aktar reazzjonijiet avversi (ADRs) rrappurtati (inċidenza ta' ≥5%) kienu (b'inċidenza bħala %) ulċera infettata fil-ġilda (12.3), ċellulite (10.3),u ostjomelite (7.2).
English: The active substance in REGRANEX is becaplermin.
Maltese: Is-sustanza attiva f'REGRANEX hi becaplermin.
English: Efficacy has not been demonstrated for ulcers of baseline surface area > 5 cm2.
Maltese: Ma ġietx dimostrata l-effikaċja fuq ulċeri ta' linja bażi ta' erja superfiċjali >5ċm2 .
English: Each gram contains E218 (methyl parahydroxybenzoate) 1.56 mg and E216 (propyl parahydroxybenzoate) 0.17 mg, see section 4.4.
Maltese: Kull gramma fiha E218 (methyl parahydroxybenzoate) 1.56 mg u E216 (propyl parahydroxybenzoate) 0.17 mg, ara sezzjoni 4.4.
English: The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000) very rare (affects less than 1 user in 10,000) not known (frequency cannot be estimated from the available data).
Maltese: Il-frekwenza ta' reazzjonjiet avversi possibli li huma mnizzla taħt huma ddefiniti skont il-konvenzjoni li jmiss: komuni ħafna (jistgħu jseħħu f'aktar minn pazjent wieħed minn kull 10) komuni (jistgħu jseħħu f'1 sa 10 pazjenti minn kull 100) mhux komuni (jistgħu jseħħu f' 1 sa 10 pazjenti minn kull 1000) rari (jistgħu jseħħu f'1 sa 10 pazjenti minn kull 10,000) rari ħafna (jistgħu jseħħu f'inqas minn pazjent wieħed minn kull 100,000) mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: 15 g of gel in a multidose tube (laminated polyethylene-lined).
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih 15 g ta' ġell f'tubi ta' dożi multipli (laminati u inforrati bil-polyethylene).
English: Systemic absorption of a single dose and multiple applications for 5 consecutive days of becaplermin to those wounds was insignificant.
Maltese: Assorbiment sistemiku ta' doża singola u applikazzjonijiet multipli għal 5 t'ijiem konsekuttivi ta' becaplermin fuq dawk il-feriti kien insinifikanti.
English: Detailed information on this medicine is available on the European Medicines Agency (EMEA) website: http://www.emea.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku ta' l-Aġenzija Ewropea dwar il-Mediċini (EMEA): http://www.emea.europa.eu
English: Česká republika JANSSEN-CILAG s.r.o.
Maltese: JANSSEN-CILAG s.r.o.
English: REGRANEX contains becaplermin, a recombinant human Platelet Derived Growth Factor-BB (rhPDGF-BB).
Maltese: REGRANEX fih becaplermin, Fattur tat-Tkabbir Derivat mill-Platelet uman rikombinanti - BB (rhPDGF-BB).
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE AUTHORISATION HOLDER (S) RESPONSIBLE FOR
Maltese: TAS-SUSTANZA(I) BIJOLOĠIKA (ĊI) ATTIVA(I)
English: Janssen-Cilag Romania Tel: +40 21 207 1800
Maltese: Johnson & Johnson d.o.o. Janssen-Cilag Romania Tel: +40 21 207 1800
English: Do not use REGRANEX:
Maltese: Tużax REGRANEX:
English: Becaplermin
Maltese: Uġigħ
English: The bundled term burning sensation consists of the preferred terms burning sensation, skin burning sensation, and application site irritation, all of which referred specifically to burning at
Maltese: Il-frażi kollettiva sensazzjoni ta' ħruq tikkonsisti fil-frażijiet preferenzjali sensazzjoni ta' ħruq, sensazzjoni ta' ħruq fil-ġilda, u irritazzjoni fis-sit tal-applikazzjoni, li kollha kemm huma irreferew speċifikament għal ħruq fis-sit tal-applikazzjoni.
English: 6.1 List of excipients carmellose sodium (E466) sodium chloride sodium acetate glacial acetic acid (E260) methyl parahydroxybenzoate (methylparaben) (E218) propyl parahydroxybenzoate (propylparaben) (E216) metacresol lysine hydrochloride water for injections
Maltese: 6.1 Lista ta' sustanzi mhux attivi carmellose sodium (E466) sodium chloride sodium acetate glacial acetic acid (E260) methyl parahydroxybenzoate (methylparaben) (E218) propyl parahydroxybenzoate (propylparaben) (E216) metacresol lysine hydrochloride ilma għal injezzjonijiet
English: Becaplermin is a human recombinant Platelet Derived Growth Factor (rhPDGF).
Maltese: Becaplermin huwa Fattur tat-Tkabbir Derivat mill-Platelet uman rikombinanti (rhPDGF-BB).
English: filiāle Latvijā Tel: + 371 678 93561
Maltese: Janssen-Cilag Polska Sp.z o.o. filiāle Latvijā Tel: + 371 678 93561
English: Each gram of gel contains 100 μg of becaplermin*.
Maltese: Kull gramma ta' ġell fih 100 μg ta' becaplermin*.
English: Contains carmellose sodium (E466), sodium chloride, sodium acetate, glacial acetic acid (E260), methyl parahydroxybenzoate (methylparaben) (E218), propyl parahydroxybenzoate (propylparaben) (E216), metacresol, lysine hydrochloride and water for injections.
Maltese: Fih carmellose sodium (E466), sodium chloride, sodium acetate, glacial acetic acid (E260), methyl parahydroxybenzoate (methylparaben) (E218), propyl parahydroxybenzoate (propylparaben) (E216), metacresol, lysine hydrochloride, ilma għal injezzjonijiet.
English: Preclinical absorption studies through full-thickness wounds were conducted in rats with a wound area of 1.4 - 1.6 cm².
Maltese: Studji ta' l-assorbiment qabel l-użu kliniku f'feriti tal-ħxuna massima ġew kondotti fuq firien b'erja ta' ferita ta' 1.4 - 1.6ċm2 .
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/101/001
Maltese: NUMRU TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/99/101/001
English: Eesti filiaal Tel: +372 617 7410
Maltese: Janssen-Cilag Polska Sp. z o.o. Eesti filiaal Tel: +372 617 7410
English: Becaplermin is produced by insertion of the gene for the B chain of human platelet derived growth factor into the yeast, Saccharomyces cerevisiae.
Maltese: Becaplermin huwa prodott permezz tal-inseriment tal-ġene għall-katina B fattur tattkabbir derivat mill-platelet uman fil-ħmira, Saccharomyces cerevisiae.
English: Osteomyelitis should be assessed by X-ray examination.
Maltese: L-ostjomelite għandu jiġi assesjat b'eżami bl-X-ray.
English: • Apply REGRANEX gel once a day using a clean cotton swab or wooden spatula.
Maltese: • Applika l-ġell REGRANEX darba kuljum billi tuża stikka tat-tajjar nadifa jew spatula talinjam.
English: If during treatment with REGRANEX no meaningful healing progress is evident after the first ten weeks of continuous therapy, treatment should be re-evaluated, and factors known to compromise healing (such as osteomyelitis, ischaemia, infection) should be re-assessed.
Maltese: Jekk waqt it-trattament b'REGRANEX ma jidhrux sinjali sinjifikanti ta' progress ta' fejqan wara 10 ġimgħat ta' terapija kontinwa, it-trattament għandu jiġi rivalwat, u fatturi magħrufa li jikkompromettu l-fejqan (bħal ostjomelite, iskemija, infezzjoni) għandhom jiġu assesjati mill-ġdid.
English: The other ingredients are: carmellose sodium (E466), sodium chloride, sodium acetate, glacial acetic acid (E260), methyl parahydroxybenzoate (methylparaben) (E218), propyl parahydroxybenzoate (propylparaben) (E216), metacresol, lysine hydrochloride and water for injections.
Maltese: L-ingredjenti l-oħra huma: carmellose sodium (E466), sodium chloride, sodium acetate, glacial acetic acid (E260), methyl parahydroxybenzoate (methylparaben) (E218), propyl parahydroxybenzoate (propylparaben) (E216), metacresol, lysine hydrochloride u ilma għall-injezzjonijiet.
English: In a preclinical study designed to determine the effects of PDGF on exposed bone, rats injected at the metatarsals with 3 or 10 μg/site (concentration of 30 or 100 μg/ml/site) of becaplermin every other day for 13 days displayed histological changes indicative of accelerated bone remodelling consisting of periosteal hyperplasia and subperiosteal bone resorption and exostosis.
Maltese: Fi studji ta' qabel l-użu kliniku ddiżinjati sabiex jiddeterminaw l-effetti ta'PDGF fuq għadam espost, firien li ġew injettati fil-metatarsali bi 3 jew 10 μg/sit (konċentrazzjoni ta' 30 jew 100 μg/ml/sit) ta' becaplermin kull jum alternattiv għal 13-il jum wera kambjamenti istoloġiċi indikattivi għal rimudellar aċċellerat tal-għadam konsistenti f'iperplasija perjostali u assorbiment mill-ġdid subperjostali talgħadam u esostożi.
English: United Kingdom JANSSEN-CILAG Ltd. Tel: +44 1 494 567567
Maltese: United Kingdom Tel: +44 1 494 567567
English: JANSSEN-CILAG Pharma GmbH.
Maltese: JANSSEN-CILAG Ltd.
English: The soft tissue adjacent to the injection site had fibroplasia with accompanying mononuclear cell infiltration reflective of the ability of PDGF to stimulate connective tissue growth.
Maltese: It-tessut artab qrib is-sit tal-injezzjoni kellu fibroplasia akkumpanjat b'infiltrazzjoni ta' ċelluli mononukleari li jirrifletti l-abilita` ta' PDGF sabiex jistimula t-tkabbir ta' tessut konnettiv.
English: Subjects recruited into these studies were diabetic adults aged 19 years or over who were suffering from at least one stage III or IV diabetic ulcer of at least 8 weeks duration.
Maltese: Individwi reklutati f'dawn l-istudji kienu adulti dijabetiċi ta' 19-il sena jew iktar li kienu qed ibatu minn ta' l-inqas stadju III jew IV ta' ulċeri dijabetiċi għal mill-inqas 8 ġimgħat.
English: REGRANEX is used for skin ulcers that:
Maltese: Sustanzi mhux attivi:
English: Applying REGRANEX
Maltese: Kif tapplika REGRANEX
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.0 of the Risk Management Plan (RMP) presented in Module 1.8.2 of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq jimpenja ruħu li jwettaq l-istudji u lattivitajiet oħra ta' farmakovigilanza kif inhu deskritt fil-Pjan ta' Farmakoviġilanza, kif inhu deċiż fil-verżjoni 1.0 tal-Pjan ta' l-Immaniġġar tar-Riskju (RMP) inkluż f' Modulu 1.8.2 ta' lAwtorizzazzjoni għat-Tqegħid fis-Suq u aġġornamenti sussegwenti ta' l-RMP kif deċiż millKumitat ghall-Prodotti Mediċinali għall-Użu mill-Bnedmin (CHMP).
English: Tel: +386 1 401 18 30
Maltese: Johnson & Johnson d.o.o. Tel: +386 1 401 18 30
English: Apply a thin layer of REGRANEX gel to the entire wound area.
Maltese: Applika saff irqiq ta' ġell REGRANEX fil-parti kollha tal-ferita.
English: REGRANEX is a clear colourless to straw-coloured gel.
Maltese: REGRANEX huwa ġell trasparenti mingħajr kulur sa kulur it-tiben.
English: Janssen-Cilag Polska Sp. z o.o.
Maltese: JANSSEN-CILAG SpA
English: - Any known malignancies (See section 4.4).
Maltese: - Kull forma magħrufa ta' tumuri malinni (Ara sezzjoni 4.4) - F'pazjenti b'ulċeri klinikament infettati (Ara sezzjoni 4.4)
English: Other side effects
Maltese: Effetti sekondarji oħra:
English: Osteomyelitis
Maltese: Ostjomelite
English: There are limited data on the effects of becaplermin overdose.
Maltese: Hemm tagħrif limitat dwar l-effetti ta' doża eċċessiva ta' becaplermin.
English: It contains a substance called becaplermin.
Maltese: Huwa fih sustanza msejħa becaplermin.
English: JANSSEN-CILAG B.V. Tel: +31 13 583 73 73
Maltese: Tel: +31 13 583 73 73
English: JANSSEN-CILAG Ltd. United Kingdom Tel: +44 1 494 567567
Maltese: JANSSEN-CILAG Pharma GmBH Tel: +43 1 610 300
English: - Hypersensitivity to the active substance or to any of the excipients.
Maltese: - Sensittività eċċessiva għas-sustanza attiva jew għal xi sustanzi mhux attivi.
English: REGRANEX is indicated, in association with other good wound care measures, to promote granulation and thereby the healing of full-thickness, neuropathic, chronic, diabetic ulcers less than or equal to 5 cm2.
Maltese: REGRANEX huwa indikat flimkien ma' miżuri tajbin għall-kura tal-feriti, sabiex jippromwovu lgranulazzjoni u l-konsegwenti fejqan ta' ulċeri dijabetiċi ta'ħxuna sħiħa newropatiċi, kroniċi ta' inqas minn jew daqs 5cm2.
English: • Cover the ulcer with a moist saline (salt) gauze dressing.
Maltese: • Għatti l-ulċera b'biċċa garża niedja bis-saline.
English: Clinical absorption studies were conducted in patients with a mean diabetic ulcer area of 10.5 cm² (range 2.3 - 43.5 cm²).
Maltese: 5ċm2 (firxa ta' 2.3 - 43.5 ċm2 ).
English: You can obtain wooden spatulas from your pharmacist
Maltese: PREKAWZJONIJIET SPEĊJALI GĦAR-RIMI TA' PRODOTTI MEDIĊINALI MHUX
English: Take special care with REGRANEX
Maltese: QABEL MA TUŻA REGRANEX
English: Since there was no consistent increase in plasma platelet-derived growth factor-BB concentrations above pre-treatment concentrations, following 14 consecutive daily topical applications to ulcers, no untoward systemic events are expected.
Maltese: Minħabba li ma kien hemm lebda żieda konsistenti fil-konċentrazzjonijiet tal-fattur ta' tkabbir-BB derivat mill-plejtlits fil-plażma, wara 14-il jum ta' applikazzjoni kuljum fuq l-ulċeri, l-ebda każijiet sistemiċi ħżiena ma huma mistennija.
English: Therapy should be continued to the maximum of 20 weeks as long as healing progress is seen on periodic evaluations.
Maltese: It-terapija għandha titkompla għal massimu ta' 20 ġimgħa sakemm jirriżulta progress ta' fejqan waqt valutazzjonijiet perjodiċi.
English: Adverse Drug Reactions Reported in Clinical Trials and Postmarketing Experience
Maltese: TWISSIJA SPEĊJALI LI L-PRODOTT MEDIĊINALI GĦANDU JINŻAMM
English: Since there was no consistent increase in plasma platelet-derived growth factor-BB concentrations above pre-treatment concentrations, following 14 consecutive daily topical applications to ulcers in man, carcinogenesis and reproductive toxicity studies have not been conducted with REGRANEX.
Maltese: Minħabba li ma kien hemm l-ebda żieda konsistenti fil-konċentrazzjonijiet tal-fattur ta' tkabbir-BB derivat mill-plejtlits filplażma aktar mill-konċentrazzjonijiet ta' qabel il-kura, wara 14-il jum ta' applikazzjoni topika kuljum fuq l-ulċeri fil-bniedem, ma ġewx kondotti studji ta' karċinoġeniċita` u tossiċita` riproduttiva b'REGRANEX.
English: JANSSEN-CILAG SpA Tel: +39 022510.1
Maltese: Tel: +39 022510.1
English: Including the above-mentioned ADRs, the following table displays ADRs that have been reported with the use of REGRANEX from either clinical trial or postmarketing experiences.
Maltese: Ġell REGRANEX huwa ġell ċar minn mingħajr kulur sa kulur it-tiben.
English: EMA/296074/2014 EMEA/V/C/003679
Maltese: EMEA/V/C/003679
English: The percentage of dogs with protective levels of antibodies for parvovirus ranged from 73 to 100% and for parainfluenza virus 73 to 97%.
Maltese: Il-perċentwal ta' klieb b'livelli protettivi ta' antikorpi għal parvovirus varja bejn 73 u 100%, għall-virus tal-parainfluwenza 73 u 97%.
English: The effectiveness of Versican Plus DHPPi was initially investigated in a field study involving 129 dogs.
Maltese: L-effikaċja ta' Versican Plus DHPPi ġiet investigata fi studju prattiku li involva 129 kelb.