FrancophonIA/ELRC3.0 huggingface dataset:
English: Zenapax is available in pack sizes of 1 or 3 vials.
Maltese: Zenapax huwa disponibbli f'daqsijiet tal-pakkett ta' 1 jew 3 kunjetti.
English: België/Belgique/Belgien N.V. Roche S.A.
Maltese: België/Belgique/Belgien
English: In a single dose toxicity study a dose of 125 mg/kg was administered intravenously to mice and showed no evidence of toxicity.
Maltese: Fi studju tossikoloġiku b'doża singola, doża ta' 125 mg/kg ingħatat ġol-vini lill-ġrieden u ma kien hemm l-ebda evidenza ta' tossiċità.
English: Daclizumab was well tolerated after single bolus intravenous or subcutaneous doses ranging from 50 to 125 mg/kg in mice, rats, and rabbits and after 28 days administration of 15 mg/kg to monkeys.
Maltese: Daclizumab kien ittollerat sew wara għotja ta' bolus wieħed ġol-vini jew taħt il-ġilda f'dożi li jvarjaw minn 50 sa 125 mg/kg fil-ġrieden, firien, u fniek u wara għoti ta' 28 jum ta' 15 mg/kg lix- xadini.
English: A health care professional will give you a suitable dose (normally 1 mg/kg of body weight) in the form of an intravenous infusion over a 15- minute period.
Maltese: Professjonist fil-qasam tas-saħħa jagħtik doża xierqa (normalment 1 mg/kg tal-piż tal-ġisem) fil-forma ta' infużjoni ġol-vini fuq medda ta' 15-il minuta.
English: Saturation of the Tac subunit of the IL-2 receptor was similar to that observed in adult patients receiving the same dose regimen.
Maltese: Is-saturazzjoni tas-subunità Tac tar-riċettur IL-2 kien simili għal dik osservata f'pazjenti adulti li ngħataw l-istess kors ta' dożaġġ.
English: Headache Dizziness
Maltese: Xagħar eċċessiv
English: Appreciable daclizumab serum levels were maintained except in 2 out of 18 monkeys that developed anti-daclizumab antibodies.
Maltese: Livelli apprezzabli ta' daclizumab fis-serum ġew miżmuma bl-eċċezzjoni ta' 2 minn 18-il xadina li żviluppaw antikorpi għal daclizumab.
English: Addition of Zenapax did not increase the number of post-transplant lymphomas, which occurred with a frequency of 1.5% in the placebotreated group and 0.7% in the Zenapax-treated group.
Maltese: Iż-żieda ta' Zenapax ma' żidietx in numru ta' limfomi wara t-trapjant, li ġraw bi frekwenza ta' 1.5% fil-grupp ikkurat bil-plaċebo u 0.7% fil-grupp ikkurat b'Zenapax.
English: Because Zenapax is an immunoglobulin, no metabolic drug-drug interactions are to be expected.
Maltese: Minħabba li Zenapax huwa immunoglobulina, m'huwiex mistenni li jkun hemm interazzjonijiet metaboliċi ma' mediċini oħrajn.
English: These side effects may occur when using Zenapax.
Maltese: Dawn l-effetti sekondarji jistgħu jseħħu meta tuża Zenepax.
English: Vascular disorders
Maltese: Limfoċele Trombożi
English: Incidence of malignancies: Three years after treatment, the incidence of malignancies was 7.8% in the placebo group compared with 6.4% in the Zenapax group.
Maltese: Frekwenza ta' tumuri: Tliet snin wara l-kura, il-frekwenza ta' tumuri kienet ta' 7.8% fil-grupp ikkurat bil-plaċebo meta mqabbla ma' 6.4% fil-grupp li ngħata Zenapax.
English: pyrosis) Abdominal distension Gastritis
Maltese: Dispepsja (inkl. pirosi) Nefħa addominali
English: In this leaflet:
Maltese: Tél/Tel:
English: Concomitant use of Zenapax with another antilymphocyte antibody therapy in the context of intensive immunosuppression with cyclosporine, mycophenolate mofetil and corticosteroids may be a factor leading to fatal infection.
Maltese: L-użu ta' Zenapax flimkien ma' terapija oħra ta' antikorpi antilimfoċitiċi fil-kuntest ta' immunosoppressjoni intensiva bl-użu ta' cyclosporine, mycophenolate mofetil u kotikosterojdi jista' jkun fattur li jwassal għal infezjoni fatali.
English: What Zenapax contains
Maltese: QABEL MA TUŻA ZENAPAX
English: Zenapax 5 mg/ml concentrate for solution for infusion is a clear, colourless to slightly yellowish liquid is supplied in vials containing 5 ml of solution.
Maltese: Zenapax 5 mg/ml konċentrat għal soluzzjoni għall-infużjoni huwa likwidu ċar, bla kulur għal ftit safrani u huwa pprovdut f'kunjetti li fihom 5 ml ta' soluzzjoni.
English: Three year graft survival rates were significantly higher among those patients who did not experience acute rejection within the first year posttransplant (n=345) compared with those who experienced acute rejection during the first year (n=190) regardless of treatment.
Maltese: Ir-rati ta' soppravivenza wara t-trapjant, wara tliet snin kienu sinifikament ogħla f'dawk il-pazjenti li ma kellhomx rifjut akut fl-ewwel sena wara t-trapjant (n=345) meta mqabbla ma' dawk li kellhom rifjut akut fl-ewwel sena (n=190) indipendentament millkura.
English: Renal function evaluated by serum creatinine and GFR was similar in both groups at three years posttransplant.
Maltese: Il-funzjoni renali vvalutata mil-livelli ta' krejatinina fis-serum u GFR kienet simili fiż-żewġ gruppi tliet snin wara t-trapjant.
English: A MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA BIJOLOĠIKA(ĊI) ATTIVA U DETENTUR(I) TA' L-AWTORIZZAZZJONI
English: Adverse event
Maltese: Avveniment avvers
English: However, of the 40 patients who received both Zenapax and antilymphocyte therapy, 8 (20.0%) died whereas of the 37 patients who received both placebo and antilymphocyte therapy, 2 (5.4%) died.
Maltese: Madankollu, mill-40 pazjent li rċevew kemm Zenapax kif ukoll terapija antilimfoċitika, 8 (20%) mietu waqt li mis-37 pazjent li rċevew il-plaċebo u terapija antilimfoċitika, mietu 2 (5.4%).
English: Zenapax is contraindicated in patients with known hypersensitivity to daclizumab or to any excipients of this product (see section 6.1).
Maltese: Zenepax huwa kontra-indikat f'pazjenti b'sensittività eċċessiva magħrufa għal daclizumab jew għal xi sustanzi mhux attivi (ara sezzjoni 6.1).
English: THE MARKETING AUTHORISATION HOLDER Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Maltese: Prodott mediċinali jingħata b'riċetta ristretta tat-tabib (ara Anness I : Sommarju tal-Karatteristiċi talProdott , sezzjoni 4.2).
English: Zenapax is used together with other immunosuppressive drugs, including cyclosporine and corticosteroids.
Maltese: Zenapax huwa użat flimkien ma' mediċini immunosoppressivi oħra, li jinkludu cyclosporine u kortikosterojdi.
English: The Tac subunit of the IL-2 receptor was saturated immediately after the first dose of 1.0 mg/kg of daclizumab and remained saturated for at least the first three months post-transplant.
Maltese: Is-subunità Tac tar-riċettur IL-2 kienet saturata immedjatament wara l-ewwel doża ta' 1.0 mg/kg ta' daclizumab u baqgħet saturata għal mill-inqas tliet xhur wara t-trapjant.
English: Hirsutism
Maltese: KUNJETT
English: Renal failure
Maltese: Disturbi vaskulari
English: Zenapax is indicated for the prophylaxis of acute organ rejection in de novo allogenic renal transplantation and is to be used concomitantly with an immunosuppressive regimen, including cyclosporine and corticosteroids in patients who are not highly immunised.
Maltese: Zenapax huwa indikat għall-profilassi kontra r-rifjut akut ta' organi fi trapjanti de novo ta' kliewi alloġeniċi u għandu jintuża flimkien ma'kors immunosoppressiv, inkluż cyclosporine u kortikosterojdi f'pazjenti li m'humiex immunizzati ħafna.
English: The twelve months mortality was 4.4% in the placebo- and 1.5% in the Zenapax-treated groups.
Maltese: L-imwiet fi tnax-il xahar kienu 4.4% fil-gruppi kkurati bil-plaċebo u 1.5% fil-gruppi kkurati b'Zenapax.
English: Diabetes mellitus Fluid overload
Maltese: Meta tuża mediċini oħra
English: The volume of Zenapax containing the appropriate dose is added to 50 ml of sterile 0.9% saline solution and is administered intravenously over a 15 minute period.
Maltese: Il-volum ta' Zenapax li fih id-doża meħtieġa huwa miżjud ma' 50 ml ta' soluzzjoni ta' melħ sterili ta' 0.9% u huwa mogħti ġol-vina fuq medda ta' 15-il minuta.
English: Administration of Zenapax inhibits IL-2-mediated activation of lymphocytes, a critical pathway in the cellular immune response involved in allograft rejection.
Maltese: L-għoti ta' Zenapax iwaqqaf l-attivazzjoni tal-limfoċiti medjata minn IL-2, passaġġ kritiku fir-rispons immunoċellulari involut fir-rifjut ta' l-organu ttrapjantat.
English: Muscle spasms
Maltese: Spażmi fil-muskoli
English: One vial with 5 ml concentrate for solution for infusion contains 25 mg daclizumab.
Maltese: Kunjett wieħed b'5 ml ta' konċentrat għal soluzzjoni għall-infużjoni fih 25 mg daclizumab.
English: The mean trough serum concentration before the fifth dose was 5.0 + 2.7 µg/ml.
Maltese: Il-konċentrazzjoni medja minima fis-serum qabel il-ħames doża kienet 5.0 ± 2.7 µg/ml.
English: Serious allergic reactions may occur following the administration of proteins.
Maltese: Jista' jkun hemm reazzjonijiet allerġiċi serji wara l-għoti ta' proteini.
English: Antibodies to daclizumab developed in approximately 9% of Zenapaxtreated patients in clinical studies but did not appear to affect efficacy, safety, serum daclizumab levels, or any other clinically relevant parameter examined.
Maltese: Antikorpi għal daclizumab żviluppaw f'bejn wieħed u ieħor 9% tal-pazjenti kkurati b'Zenapax fi provi kliniċi, iżda ma deherx li kien hemm xi effett fuq l-effikaċja, s-sigurtà, l-livelli ta' daclizumab fisserum, jew fuq xi parametru ieħor eżaminat ta' relevanza klinika.
English: Renal tubular necrosis Hydronephrosis Renal disorder (damage) Haemorrhage urinary tract Urinary retention Urinary tract disorder Oliguria
Maltese: Disturbi fil-kliewi (ħsara) Fsada fl-apparat urinarju Żamma ta' l-awrina Disturbi fl-apparat urinarju Oligurja
English: Oedema
Maltese: Fsada
English: Some side effects are more likely to occur in children than in adults, these include diarrhoea, pain following surgery, fever, vomiting, high blood pressure, itchy skin, infections of the nose and throat and infections in the urine.
Maltese: Uħud mill-effetti sekondarji huma aktar probabbli li jseħħu fit-tfal milli fl-adulti, dawn jinkludu dijarea, uġigħ wara operazzjoni, deni, rimettar, pressjoni tad-demm għolja, ħakk fil-ġilda, infezzjonijiet fl-imnieħer u l-griżmejn u infezzjonijiet fl-awrina.
English: Take special care with Zenapax - if you have ever had an allergic reaction to other immunosuppressive medicines, which help to suppress the body's natural defence mechanisms.
Maltese: Oqgħod attent ħafna b'Zenapax: - jekk qatt kellek reazzjoni allerġika għall-mediċini immunosoppressivi oħra, li jgħinu biex iwaqqfu l-mekkaniżmi naturali ta' difiża tal-ġisem
English: Store in a refrigerator (2 °C - 8 °C) Do not freeze
Maltese: Aħżen fi friġġ (2 °C - 8 °C) Tagħmlux fil-friża
English: Daclizumab is excreted in cynomolgus monkey milk (see section 5.3).
Maltese: Daclizumab jintrema fil-ħalib tax-xadini cynomolgus (ara sezzjoni 5.3). Mhux magħruf jekk Zenepax jintremiex fil-ħalib uman.
English: Arthralgia
Maltese: Parastesja
English: No incompatibility between Zenapax and polyvinyl chloride bags or infusion sets has been observed.
Maltese: Ma kienet osservata l-ebda inkompatibilità bejn Zenapax u boroż ta' polyvinyl chloride jew settijiet għall-infużjoni.
English: Of these 14 Zenapax patients, 4 died more than 90 days after receiving their last dose of Zenapax, making it unlikely that Zenapax had a role in the infection related death.
Maltese: Minn dawn l-14-il pazjent li ngħataw Zenapax, 4 mietu wara aktar minn 90 ġurnata li ngħataw l-aħħar doża ta' Zenapax, li jindika li x'aktarx Zenapax ma kellux rwol fil-mewt relatata ma' infezzjoni.
English: Women of childbearing potential must use an effective contraceptive method during Zenapax therapy and continue its use for an additional 4 months following the last dose of Zenapax.
Maltese: Nisa li għandhom potenzjal li jkollhom t-tfal għandhom jużaw mezz effettiv ta' kontraċezzjoni waqt terapija b'Zenepax u sa 4 xhur wara l-aħħar doża ta' Zenepax.
English: The recommended regimen of daclizumab will maintain serum concentrations sufficient to saturate IL-2R alpha receptors on activated T lymphocytes for more than 90 days post transplantation in the majority of patients.
Maltese: IL-2R alfa fuq limfoċiti T attivati għal aktar minn 90 jum wara t-trapjant fil-maġġoranza tal-pazjenti.
English: - Store in a refrigerator (2 °C - 8 °C).
Maltese: - Aħżen fi friġġ (2 °C - 8 °C). - Tagħmlux fil-friża.
English: Abdominal pain upper (epigastric pain) Haemorrhoids
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: Deaths occurring during the first 6 months post-transplant were reported in 3.4% of the placebo- and in 0.6% of the Zenapax-treated groups.
Maltese: Imwiet li seħħew tul l-ewwel 6 xhur wara t-trapjant kienu rrapportati fi 3.4% tal-gruppi kkurati bilplaċebo u f'0.6% tal-gruppi kkurati b'Zenapax.
English: Strength Pharmaceutical Form
Maltese: Isem(inventat) Qawwa Għamla farmaċewtika
English: The reference Member State (RMS) is the Netherlands and 12 concerned Member States (CMS) are involved: Austria, Belgium, Czech Republic, Denmark, France, Germany, Hungary, Ireland, Italy, Poland, Spain and the United Kingdom.
Maltese: L-Istat Membru ta' referenza (RMS) huwa l-Pajjiżi l-Baxxi u hemm 12-il Stat Membru kkonċernat (CMS) involuti: l-Awstrija, il-Belġju, ir-Repubblika Ċeka, id-Danimarka, Franza, il-Ġermanja, l-Ungerija, l-Irlanda, l-Italja, il-Polonja, Spanja u r-Renju Unit.
English: • The pharmaceutical similarity of Melosolute 40 mg/ml and Metacam 20 mg/ml formulations.
Maltese: • Is-similarità farmaċewtika tal-formulazzjonijiet ta' Melosolute 40 mg/ml u ta' Metacam 20 mg/ml.
English: Belgium CP-Pharma Handelsgesellschaft mbH Ostlandring 13
Maltese: Id-Danimarka CP-Pharma Handelsgesellschaft mbH Ostlandring 13
English: This is a ‘hybrid' application according to Article 13(3) Directive 2001/82/EC, as amended, referring to the centrally authorised reference product Metacam 20 mg/ml solution for injection for cattle, pigs and horses (EU/2/97/004).
Maltese: Din hija applikazzjoni ‘ibrida' skont lArtikolu 13(3) tad-Direttiva 2001/82/KE, kif emendata, li tirreferi għall-prodott ta' referenza awtorizzat ċentralment Metacam 20 mg/ml soluzzjoni għal injezzjoni għall-baqar, majjali u żwiemel (EU/2/97/004).
English: The tissue concentration levels were derived from samples taken at 4 hours and at 2, 4 and 8 days (20 mg/ml study) or 1, 3 and 5 days after the final administration (40 mg/ml study).
Maltese: Il-livelli talkonċentrazzjoni fit-tessut kienu derivati minn kampjuni li ttieħdu 4 sigħat u 2, 4 u 8 ijiem (studju ta' 20 mg/ml) jew 1, 3 u 5 ijiem wara l-għoti finali (studju ta' 40 mg/ml).
English: • In pigs, the proposed indications are for use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation, and for adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome) with appropriate antibiotic therapy.
Maltese: • Fil-majjali, l-indikazzjonijiet proposti huma għall-użu f'mard lokomotorju mhux infettiv biex inaqqas is-sintomi ta' zappzip u infjammazzjoni, u għal terapija addizzjonali fil-kura ta' settiċemija puwerperali u tossemija (sindrome ta' mastitis-metritis-agalactia) b'terapija antibijotika adegwata.
English: CP-Pharma
Maltese: L-Awstrija
English: Melosolute differs from the reference product through different strength of the active substance, meloxicam (40 mg/ml versus 20 mg/ml) and a different concentration of one of the excipients.
Maltese: Melosolute huwa differenti mill-prodott ta' referenza minħabba qawwa differenti tas-sustanza attiva, meloxicam (40 mg/ml kontra 20 mg/ml) u konċentrazzjoni differenti ta' wieħed mill-eċċipjenti.
English: In the CVMP list of questions, the applicant was requested to address (i) the effect of comparing results from separately conducted studies, (ii) the effect that the number of animals sampled has on the reliability of the results (taking into account that for a standard bioequivalence study the test/reference ratio of the pivotal parameters must fall within predefined statistical limits); (iii) the timing and number of sampling points and how this relates to characterisation of the rate and extent of absorption; and (iv) how meloxicam concentrations in the tissues sampled (liver, kidney, muscle and injection site) relate to plasma pharmacokinetics.
Maltese: Fil-lista ta' mistoqsijiet tas-CVMP, l-applikant intalab jindirizza (i) l-effett tat-tqabbil ta' riżultati minn studji li saru separatament, (ii) l-effett li l-għadd ta' annimali kampjunati għandu fuq l-affidabbiltà tarriżultati (b'kunsiderazzjoni li għal studju standard ta' bijoekwivalenza, il-proporzjon tal-parametri pivotali tat-test/referenza għandhom jaqgħu f'limiti statistiċi definiti minn qabel); (iii) iż-żmien u lgħadd ta' punti ta' kampjunar u kif dan jirrelata mal-karatterizzazzjoni tar-rata u l-limitu ta' assorbiment; u (iv) kif il-konċentrazzjonijiet ta' meloxicam fit-tessuti kampjunati (fwied, kliewi, muskoli u sit tal-injezzjoni) jirrelataw mal-farmakokinetika fil-plasma.
English: Meloxicam is a NSAID of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, anti-exudative, analgesic and antipyretic effects.
Maltese: Meloxicam huwa NSAID tal-klassi ta' oxicam li jaġixxi b'inibizzjoni tas-sintesi tal-prostaglandini, b'hekk jeżerċita effetti kontra l-infjammazzjoni, kontra t-tnixxija, analġesiċi u antipiretiċi.
English: Evaluation of the benefit-risk balance
Maltese: Evalwazzjoni tal-bilanċ tal-benefiċċju-riskju
English: Some differences in pharmacokinetic parameters are attributed to different size/age of animal.
Maltese: Xi differenzi fil-parametri farmakokinetiċi huma attribwiti għaddaqs/età differenti tal-annimali.
English: While there is a theoretical risk of increased inflammation at the site of injection due to increased tonicity of the 40 mg/ml formulation compared with the lower concentration of the reference product, injection site clinical observations and gross and microscopic pathology conducted during the residues study indicated that local inflammatory responses were minimal.
Maltese: Filwaqt li hemm riskju teoretiku ta' żieda fl-infjammazzjoni fis-sit tal-injezzjoni minħabba żieda fittoniċità tal-formulazzjoni ta' 40 mg/ml meta mqabbla mal-konċentrazzjoni l-aktar baxxa tal-prodott ta' referenza, osservazzjonijiet kliniċi fis-sit tal-injezzjoni u patoloġija grossa u mikroskopika mwettqa matul l-istudju dwar ir-residwi indikaw li reazzjonijiet infjammatorji lokali kienu minimi.
English: This is a generic ‘hybrid' application in which the applicant is extrapolating pre-clinical and clinical data from the reference product Metacam 20 mg/ml.
Maltese: Din hija applikazzjoni "ibrida" ġenerika li fiha l-applikant qed jestrapola dejta pre-klinika u klinika millprodott ta' referenza Metacam 20 mg/ml.
English: However, the applicant claims there is a very fast distribution of meloxicam from the intramuscular injection site into the general circulation and subsequently a very fast elimination from tissues like liver, kidney and muscle taking into consideration the identical elimination half-life in pigs after intravenous or intramuscular administration, which justifies the claim for waiver of a bioequivalence study in pigs based on results of the residue depletion study in comparison to the Metacam 20 mg/ml product.
Maltese: Madankollu, l-applikant isostni li hemm distribuzzjoni malajr ħafna ta' meloxicam mis-sit ta' injezzjoni ġol-muskoli lejn iċ-ċirkolazzjoni ġenerali u sussegwentement eliminazzjoni malajr ħafna minn tessuti bħall-fwied, kliewi u muskoli b'kunsiderazzjoni tal-eliminazzjoni half-life identika fil-majjali wara għoti ġol-vini jew ġol-muskoli, li jiġġustifika t-talba għal tneħħija ta' studju ta' bijoekwivalenza fil-majjali abbażi tar-riżultati tal-istudju dwar it-tnaqqis tar-residwi meta mqabbla mal-prodott Metacam 20 mg/ml.
English: It is noticed that peak plasma concentration was reached 1 hour after the second administration in the residue depletion study using 14C-Meloxicam 20 mg/ml and declined rapidly from a Cmax of 1730 ng equivalent/ml at 1 hour after administration and over the next 95 hours (no sampling time points stated).
Maltese: Ġie nnotat li fl-istudju dwar ittnaqqis tar-residwi bl-użu ta' 14C-Meloxicam 20 mg/ml il-konċentrazzjoni massima fil-plasma ntlaħqet siegħa wara t-tieni għoti u naqset malajr minn Cmax ta' 1730 ng ekwivalenti/ml siegħa wara l-għoti u matul il-95 siegħa ta' wara (ma ġew iddikjarati l-ebda punti fiż-żmien ta' kampjunar).
English: Melosolute 40 mg/ml solution for injection for cattle, pigs and horses contains meloxicam 40 mg/ml.
Maltese: Melosolute 40 mg/ml soluzzjoni għal injezzjoni għall-baqar, majjali u żwiemel fih meloxicam 40 mg/ml.
English: • the residues depletion data provided no firm evidence that allows quantification of any difference in rate and extent of absorption of meloxicam between Melosolute 40 mg/ml and Metacam 20 mg/ml, and therefore to quantify its impact on clinical safety and efficacy; the particulars concerning the target species pigs that were submitted in support of the application do not comply with Article 13 of Directive 2001/82/EC, and consequently do not satisfy the criteria for authorisation in respect of safety and efficacy for the target species pigs.
Maltese: • id-dejta dwar it-tnaqqis tar-residwi ma pprovdiet l-ebda evidenza soda li tippermetti kwantifikazzjoni ta' xi differenza fir-rata u l-limitu ta' assorbiment ta' meloxicam bejn Melosolute 40 mg/ml u Metacam 20 mg/ml, u għalhekk biex l-impatt tiegħu fuq is-sigurtà u leffikaċja klinika jiġi kkwantifikat; id-dettalji dwar il-majjali bħala l-ispeċi fil-mira li kienu sottomessi b'appoġġ tal-applikazzjoni mhumiex konformi mal-Artikolu 13 tad-Direttiva 2001/82/KE, u konsegwentement ma jissodisfawx il-kriterji għal awtorizzazzjoni fir-rigward tas-sigurtà u l-effikaċja għall-majjali bħala l-ispeċi fil-mira.
English: The test and reference products are qualitatively identical aqueous solutions, which differ only in the concentration of meloxicam and one of the excipients.
Maltese: Il-prodotti tat-test u ta' referenza huma soluzzjonijiet milwiema kwalitattivament identiċi, li jvarjaw biss fil-konċentrazzjoni ta' meloxicam u wieħed mill-eċċipjenti.
English: • as this is a generic ‘hybrid' application, in the absence of other data the principles of bioequivalence would need to be applied to determine the expected safety and efficacy of the product by extrapolation of the pre-clinical and clinical data from the reference product.
Maltese: • peress li din hija applikazzjoni ‘ibrida' ġenerika, fin-nuqqas ta' dejta oħra, il-prinċipji ta' bijoekwivalenza jkunu jeħtieġu jiġu applikati biex jiġu determinati s-sigurtà u l-effikaċja mistennija tal-prodott permezz ta' estrapolazzjoni tad-dejta pre-klinika u klinika mill-prodott ta' referenza.
English: Any increase in the rate/extent of absorption has not been quantified for Melosolute 40 mg/ml in a comparative pharmacokinetic study with the reference product and it could have implications in terms of target animal safety.
Maltese: Kwalunkwe żieda fir-rata/limitu ta' assorbiment ma ġietx ikkwantifikata għal Melosolute 40 mg/ml fi studju farmakokinetiku komparattiv mal-prodott ta' referenza u setgħet kellha implikazzjonijiet f'termini tas-sigurtà tal-annimali fil-mira.
English: The CVMP acknowledged the similarity of the formulations of the Melosolute 40 mg/ml and Metacam 20 mg/ml in terms of their excipients.
Maltese: Is-CVMP irrikonoxxa s-similarità tal-formulazzjonijiet ta' Melosolute 40 mg/ml u Metacam 20 mg/ml f'termini tal-eċċipjenti tagħhom.
English: The main remaining risk arises from the uncertainty due to lack of data on the pharmacokinetic profile and exposure to meloxicam following intramuscular injection of the 40 mg/ml test product in pigs.
Maltese: Ir-riskju ewlieni li fadal jirriżulta mill-inċertezza minħabba nuqqas ta' dejta dwar il-profil farmakokinetiku u espożizzjoni għal meloxicam wara injezzjoni ġol-muskoli tal-prodott tat-test ta' 40 mg/ml fil-majjali.
English: • Even if the formulations were inequivalent, the lack of bioequivalence would not be clinically relevant due to a wide therapeutic window.
Maltese: • Anki jekk il-formulazzjonijiet ma kinux ekwivalenti, in-nuqqas ta' bijoekwivalenza ma jkunx klinikament rilevanti minħabba marġini terapewtika wiesgħa.