FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH shall ensure the traceability of each implant by using unique identification numbers assigned to each biopsy (Biopsy ID number), membrane and final MACI product (MAH ID number), as described in the Risk Management Plan.
Maltese: Il-MAH għandu jiżgura t-traċċabilità ta' kull impjant billi juża numri ta' identifikazzjoni uniċi assenjati lil kull bijopsija (Numru tal-ID tal-bijopsija), membrana u prodott tal-MACI finali (numru tal-ID tal-MAH), kif deskritt fil-Pjan ta' Ġestjoni tar-Riskji.
English: • Severe osteoarthritis of the knee.
Maltese: • Osteoartrite severa tal-irkoppa.
English: MACI is supplied in 1 to 2 dishes, which are placed into a 95kPa pouch (outer bag) with absorbent material for transport.
Maltese: MACI jiġi fornut bħala dixx wieħed sa 2 dixxijiet, li jitqiegħdu f'borża 95kPa (borża ta' barra) b'materjal assorbenti għat-trasport.
English: Each implantation matrix consists of characterised autologous chondrocytes on a 14.5 cm² Type I/III collagen membrane, at a density of 500,000 to 1,000,000 cells per cm2, to be trimmed by the surgeon to the size and shape of the defect.
Maltese: Kull matriċi għall-impjantazzjoni hija magħmula minn kondroċiti awtologi karatterizzati fuq membrana tal-kollaġen tat-Tip I/III ta' 14.5 ċm², f'densità ta' 500,000 sa 1,000,000 ċellola kull ċm2, li trid tiġi mirquma mill-kirurgu għad-daqs u l-forma tad-difett.
English: MACI is indicated for the repair of symptomatic, full-thickness cartilage defects of the knee (grade III and IV of the Modified Outerbridge Scale) of 3-20 cm in skeletally mature adult patients.
Maltese: MACI huwa indikat għat-tiswija ta' difetti sintomatiċi, fil-ħxuna kollha tal-qarquċa tal-irkoppa (grad III u IV tal-Iskala Modifikata ta' Outerbridge) ta' 3-20 ċm f'pazjenti adulti bi skeletru matur.
English: Visit 10 (Week 104) Stratified by centre
Maltese: L-10 Viżta (Ġimgħa 104)
English: Based on the exposure of more than 6,000 patients to MACI treatment in the knee, complications may be related to the arthrotomy procedure, general complications related to surgical intervention, other knee pathology (such as ligamentous or meniscal pathology), or the biopsy procurement.
Maltese: Abbażi tal-espożizzjoni ta' aktar minn 6,000 pazjent għal kura b'MACI fl-irkoppa, komplikazzjonijiet jistgħu jkunu relatati mal-proċedura ta' artrotomija, komplikazzjonijiet ġenerali relatati mal-intervent kirurġiku, patoloġija oħra fl-irkoppa (bħal patoloġija fil-ligament jew fil-menisku), jew bil-mod kif inkisbet il-bijopsija.
English: Characterised viable autologous chondrocytes expanded ex vivo expressing chondrocyte-specific marker genes, seeded onto a CE marked porcine derived Type I/III collagen membrane.
Maltese: Kondroċiti awtologi vijabbli karatterizzati mkabbra ex vivo li jesprimu ġeni markaturi speċifiċi għallkondroċit, miżrugħa fuq membrana tal-kollaġen tat-Tip I/III li ġejja mill-majjali u mmarkata b'CE.
English: Responded
Maltese: Tqala
English: Controlled physiotherapy, including early mobilisation, range-of-motion exercises, and partial weightbearing is recommended as soon as possible to promote graft maturation and to reduce the risk of postoperative thromboembolic events and joint stiffness.
Maltese: Fiżjoterapija kkontrollata, inkluż mobilizzazzjoni bikrija, eżerċizzji għal firxa ta' movimenti, u rfigħ parzjali tal-piż tal-ġisem huma rrakkomandati malajr kemm jista' jkun biex jippromwovu maturazzjoni tat-trapjant u biex jitnaqqas ir-riskju ta' avvenimenti tromboemboliċi u ebusija fil-ġogi wara loperazzjoni.
English: • Localised surgical site infection
Maltese: • Infezzjoni lokalizzata fis-sit tal-kirurġija
English: Missing * KOOS Response Rate: Responder is defined as an improvement of the Knee Injury and Osteoarthritis Outcome Score from baseline of minimal 10 points of a scale of 100.
Maltese: Mhux Stratifikata Irrispondew Ma rrispondewx Nieqsa * Rata ta' rispons skont KOOS: Persuna li rrispondiet hija definita bħala titjib fil-punteġġ talKorriment fl-Irkoppa u r-riżultat tal-Osteoartrite mil-linja bażi għal minimu ta' 10 punti minn skala ta' 100.
English: Autologous chondrocytes on a 14.5 cm² Type I/III collagen membrane, at a density of between 500,000 and 1,000,000 cells per cm
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kondroċiti awtologi fuq membrana tal-kollaġen tat-Tip I/III ta' 14.5 ċm², f'densità ta' bejn 500,000 u 1,000,000 ċellola kull ċm
English: MACI must be administered by a surgeon specifically trained and qualified in the use of MACI.
Maltese: MACI għandu jingħata minn kirurgu speċifikament imħarreġ u kwalifikat fl-użu ta' MACI.
English: Patients with local inflammations or active infections in the bone, joint, and surrounding soft tissue should be temporarily deferred until documented recovery.
Maltese: Pazjenti b'infjammazzjonijiet lokali jew b'infezzjonijiet attivi fl-għadam, fil-ġogi, u fit-tessut artab talmadwar għandhom jiġu temporanjament differiti sakemm ikun hemm irkupru dokumentat.
English: Matrix applied characterised autologous cultured chondrocytes This medicine is subject to additional monitoring.
Maltese: Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: Graft delamination Graft complication Graft hypertrophy
Maltese: Kif għandek tuża MACI Effetti sekondarji possibbli Kif taħżen MACI
English: • The importance of explaining to the patients: o The risks asociated with the surgical procedures and MACI o The need for clinical follow-up o The need for rehabilitation following articular cartilage repair
Maltese: • L-importanza li wieħed jispjega lill-pazjenti: o Ir-riskji assoċjati mal-proċeduri kiruġiċi u ma' MACI o Il-ħtieġa għal follow-up kliniku o Il-ħtieġa għal riabilitazzjoni wara tiswija tal-kartilaġini artikulari
English: • Details of the implantation procedure
Maltese: • Dettalji tal-proċedura ta' impjantazzjoni
English: Visit 10 (Week 104) Unstratified
Maltese: Viżta (Ġimgħa 104)
English: The active substance of MACI consists of viable autologous human cartilage cells on a 14.5 cm² Type I/III collagen membrane, at a density of between 0.5 and 1 million cells per cm
Maltese: Is-sustanza attiva ta' MACI tikkonsisti minn ċelloli awtologi vijabbli tal-qarquċa umana fuq membrana tal-kollaġen tat-Tip I/III ta' 14.5 ċm², f'densità ta' bejn 0.5 u miljun ċellola kull ċm
English: Local treatment guidelines regarding the use of antibiotic prophylaxis around orthopaedic surgery should
Maltese: Għandhom jiġu segwiti l-linji gwida lokali tal-kura rigward l-użu ta' profilassi antibijotika f'kirurġija ortopedika.
English: Implantation of MACI is to be performed during arthrotomy under sterile conditions.
Maltese: Limpjantazzjoni ta' MACI għandha ssir waqt artrotomija taħt kundizzjonijiet sterili.
English: The use of MACI in this age group has not been studied.
Maltese: L-użu ta' MACI f'dan il-grupp ta' età ma ġiex studjat.
English: The final MACI implant will be sent back to your surgeon.
Maltese: L-impjant finali ta' MACI se jintbagħat lura lill-kirurgu tiegħek.
English: Typical clinical pharmacokinetic (ADME) studies have not been performed on MACI.
Maltese: Ma saru l-ebda studji kliniċi farmakokinetiċi tipiċi (ADME) fuq MACI.
English: Each dish is sealed in a gamma-irradiated clear plastic bag.
Maltese: Kull dixx jiġi ssiġillat f'borża tal-plastik ċar ittrattata bir-raġġi gamma.
English: • Educational material on the surgical procedures
Maltese: • Materjal edukattiv fuq follow-up xieraq
English: • Haemarthrosis
Maltese: Infjammazzjoni Ipertermija
English: • Localised surgical site inflammation
Maltese: • Materjal edukattiv fuq il-proċeduri kirurġiċi
English: The patient's haemostatic functions should be screened prior to surgery.
Maltese: Il-funzjonijiet emostatiċi tal-pazjent għandhom jiġu evalwati qabel il-kirurġija.
English: • Details of the rehabilitation program
Maltese: • Dettalji dwar il-programm ta' riabilitazzjoni
English: • Patients with a femoral epiphyseal growth plate that is not fully closed.
Maltese: • Pazjenti bi growth plate tal-epiphysis tal-wirk li għadha ma ngħalqitx kompletament.
English: Seventy-two patients received MACI, and 72 were treated with microfracture.
Maltese: Tnejn u sebgħin pazjent irċevew MACI, u 72 irċevew kura b'mikrofrattura.
English: • difficulty breathing, chest pain and palpitations • leg swelling, leg pain and redness
Maltese: • diffikultà bit-teħid tan-nifs, uġigħ fis-sider u palpitazzjonijiet
English: • The need for rehabilitation following articular cartilage repair
Maltese: • Il-ħtieġa għal riabilitazzjoni wara tiswija tal-kartilaġini artikulari
English: Package leaflet: Information for the user MACI 500,000 to 1,000,000 cells/cm2 for implantation
Maltese: IL-PRODOTT MEDIĊINALI MACI 500,000 sa 1,000,000 ċellola/ċm
English: Fibrin sealants containing formaldehyde must not be used with MACI, since formaldehyde is cytotoxic to the chondrocytes.
Maltese: Siġillanti tal-fibrina li fihom il-formaldehyde ma għandhomx jintużaw ma' MACI, minħabba li lformaldehyde huwa tossiku għall-kondroċiti.
English: Symptomatic graft hypertrophy is acomplication that may occur with MACI.
Maltese: Ipertrofija sintomatika tat-trapjant hija komplikazzjoni li jista' jkun li sseħħ b'MACI.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: MACI 500,000 - 1,000,000 cells/cm implantation matrix
Maltese: U MNEJN GĦANDU JINGĦATA MACI 500,000 - 1,000,000 ċellola/ċm
English: • Meniscal pathology: unstable or torn meniscus requires repair, replacement, or partial meniscectomy.
Maltese: • Patoloġija meniskali: menisku instabbli jew imċarrat jeħtieġ jissewwa, jiġi sostitwit, jew issir menisektomija parzjali.
English: Given the local nature of the medicinal product, adverse reactions of MACI on pregnancy are not anticipated.
Maltese: Minħabba n-natura lokali tal-prodott mediċinali, mhuwiex mistenni li jkun hemm reazzjonijiet avversi ta' MACI fuq it-tqala.
English: MARKETING AUTHORISATION HOLDER Vericel Denmark ApS
Maltese: Kastrup, Id-Danimarka
English: Clinical pharmacology studies have not been conducted on MACI.
Maltese: Ma saru l-ebda studji kliniċi farmakoloġiċi fuq MACI.
English: Each dish contains 1 implantation matrix, held in place by a green polycarbonate x-ring and closed with a green polycarbonate cover for shipment.
Maltese: Kull dixx fih matriċi waħda għall-impjantazzjoni, li tinżamm fil-post b'x-ring aħdar tal-polikarbonat u jingħalaq b'għatu aħdar tal-polikarbonat biex jiġi trasportat.
English: Older people (over 65 years of age)
Maltese: Persuni akbar fl-età ('l fuq minn 65 sena)
English: MACI will be sent back to the surgeon.
Maltese: MACI jintbagħat lura lill-kirurgu.
English: Other complications have been identified as causally related to MACI.
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata
English: • joint stiffness/numbness
Maltese: • ebusija/tnemnim fil-ġog
English: Medicinal products on “restricted” medical prescription, reserved for use in certain specialised areas (see Annex I: Summary of Product Characteristics, section 4.2).
Maltese: Prodotti mediċinali li jingħataw b'riċetta ristretta tat-tabib għall-użu f'ċerti oqsma speċjalizzati (ara Anness I: Sommarju tal- Karatteristiċi tal-Prodott, sezzjoni 4.2).
English: • are allergic to any of the ingredients of MACI (listed in section 6), or porcine products (derived from pigs), bovine serum (a protein derived from cows) or gentamicin (an antibiotic)
Maltese: • allerġiku għal xi sustanza ta' MACI (elenkati fis-sezzjoni 6), jew għal prodotti tal-majjali
English: MACI will be released following successful results from assays which assess chondrocyte viability, identity, potency, minimum cell number, endotoxin, pre-release sterility, and mycoplasma.
Maltese: MACI jiġi rilaxxat wara riżultati pożittivi minn analiżi li jevalwaw il-vijabilità, l-identità, il-qawwa, l-għadd minimu ta' ċelloli, l-endotossini, l-isterilità ta' qabel ir-rilaxx, u l-mikoplasma tal-kondroċiti.
English: Your doctor may give you other medicines to help reduce any side effects (see section 2 “Warnings and precautions”).
Maltese: It-tabib tiegħek jista' jagħtik mediċini oħra biex jgħin inaqqas xi effetti sekondarji (ara sezzjoni 2 “Twissijiet u prekawzjonijiet”).
English: MACI will be secured in place using a fibrin sealant.
Maltese: MACI jinżamm filpost permezz ta' siġillant tal-fibrina.
English: In the pivotal study of MACI, patients were excluded if they had a history of osteoarthritis (Kellgren-Lawrence Grade 3 or 4) in the target knee, or concomitant inflammatory disease.
Maltese: Fl-istudju pivotali ta' MACI, jekk pazjenti kellhom storja ta' osteoartrite (Kellgren-Lawrence tal-Grad 3 jew 4) fl-irkoppa fil-mira, jew mard infjammatorju konkomittanti ġew esklużi.
English: • Malalignment: the tibio-femoral joint should be properly aligned.
Maltese: • it-trapjant jista' jinqata' kompletament jew parzjalment mid-difett fil-ġog.
English: • If you get any side effects talk to your doctor, surgeon or physical therapist.
Maltese: • Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib, lill-kirurgu jew lit-terapista fiżiku tiegħek.
English: There is limited experience with delivery of MACI to the knee via arthroscopy, however, arthroscopic techniques may be used to apply MACI at the discretion of the treating physician.
Maltese: Il-kirurgu tiegħek sejjer jispjegalek x'inhuma l-proċeduri ta' artrotomija u artroskopija.
English: Ask your doctor or surgeon for more information as to which pain medicine you can safely use.
Maltese: Staqsi lit-tabib jew lill-kirurgu tiegħek għal aktar informazzjoni dwar liema mediċina kontra l-uġigħ tista' tuża b'mod sigur.
English: • the biopsy is of insufficient quality to produce MACI for you
Maltese: • il-bijopsija ma tkunx ta' kwalità suffiċjenti biex isir MACI għalik
English: While oral use of pain medication is recommended for post-surgical pain relief, intra-articular administration of analgesics is not recommended as studies have shown adverse effects on articular cartilage and chondrocytes with exposure.
Maltese: MACI għandu jiġi impjantat biss minn kirurgi li jkunu tħarrġu speċifikament għal din it-tip ta' kirurġija.
English: Implant site oedema
Maltese: Sustanzi oħra:
English: Abnormal varus or valgus loading of the tibio-femoral joint may jeopardise the implant and should be addressed with a corrective osteotomy or similar procedure.
Maltese: Tagħbija abnormali varus jew valgus tal-ġog tibjo-femorali tista' tipperikola l-impjant u għandha tiġi indirizzata b'osteotomija korrettiva jew bi proċedura simili.
English: The Marketing Authorisation Holder (MAH) shall agree the content and the delivery of the Educational Program with the National Compentent Authority prior to the launch of MACI in that Member State.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) għandu jaqbel fuq il-kontenut u fuq ilmod kif jitwassal il-Programm Edukattiv mal-Awtorità Nazzjonali Kompetenti qabel il-lanċjar ta' MACI f'dak l-Istat Membru.
English: PHARMACEUTICAL FORM AND CONTENTS
Maltese: TAL-PRODOTT MEDIĊINALI
English: Date of first authorisation: 10/12/2019
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 10/12/2019
English: The mean AUC0-24 was 100 ng*h/ml (± 51.7).
Maltese: L-AUC0-24 medja kienet ta' 100 ng*h/ml (± 51.7).
English: 80689 Munich
Maltese: 80689 Muenchen
English: Klifovet AG Geyerspergerstrasse 27 80689 Muenchen Germany
Maltese: Klifovet AG Geyerspergerstr. 27 80689 Munich
English: Limited data are available on the reproductive toxicity of mirtazapine.
Maltese: Id-data disponibbli dwar it-tossiċità riproduttiva ta' mirtazapine hija limitata.
English: Mirtazapine (as hemihydrate) 2 mg
Maltese: Mirtazapine (bħala hemihydrate) 2 mg
English: Excipients: Butylhydroxytoluene (E321) 0.01 mg
Maltese: Butylhydroxytoluene (E321) 0.01 mg
English: Tapioca starch polymethylsilsesquioxane
Maltese: Lamtu tat-tapjoka polymethylsilsquesoxane
English: Each dose of 0.1 g contains:
Maltese: Kull doża ta' 0.1 g fiha:
English: Application site reaction(s) (erythema, crust/scab, residue, scaling/dryness, flaking, head shaking, dermatitis or irritation, alopecia, and pruritus) and behavioural changes (increased vocalisation, hyperactivity, disoriented state or ataxia, lethargy/weakness, attention seeking and aggression) occurred very commonly in safety and clinical studies.
Maltese: Ir-reazzjoni(jiet) fis-sit tal-applikazzjoni (eritema, qoxra, residwu, esfoljazzjoni/ġilda xotta, tqaxxir, ċaqliq tar-ras min-naħa għall-oħra, dermatite jew irritazzjoni, alopeċja, u ħakk) u tibdil fl-imġiba (żieda filvokalizzazzjoni, iperattività, stat diżorjentat jew atassija, letarġija/dgħufija, ġbid ta' attenzjoni u aggressjoni) seħħew b'mod komuni ħafna fi studji kliniċi u ta' sigurtà.
English: Plastic bottle
Maltese: Flixkun tal-plastik
English: The mean terminal half-life of mirtazapine was 19.9 h (± 3.70) and the mean AUC0-24 was 400 ng*h/ml (±100).
Maltese: In nofs ħajja terminali medja ta' mirtazapine kienet ta' 19.9 sigħat (± 3.70) u l-AUC0-24 medja kienet ta' 400 ng*h/ml (± 100).
English: Lot {number}
Maltese: U/JEW UŻU
English: The veterinary medicinal product is a skin sensitiser.
Maltese: Il-prodott mediċinali veterinarju huwa sensitizzatur tal-ġilda.
English: Transdermal use.
Maltese: Mhux applikabbli.
English: Diethylene glycol monoethyl ether Caprylocaproyl polyoxyglycerides Oleyl alcohol
Maltese: Monoetiletere tal-glikol dietileniku Caprylocaproyl polyoxyglycerides
English: Bioavailability following topical administration was 34% (6.5 to 89%) compared to oral administration during the first 24 hours and 65% (40.1 to 128.0%) based on AUC0-∞.
Maltese: Il-bijodisponibilità wara l-għoti topiku kienet ta' 34 % (6.5 sa 89 %) meta mqabbla mal-għoti orali waqt l-ewwel 24 siegħa u ta' 65 % (40.1 sa 128.0 %) abbażi tal-AUC0-∞.
English: In the case of hepatic disease, elevated hepatic enzyme levels may be observed.
Maltese: Fil-każ ta' mard tal-fwied, jistgħu jiġu osservati livelli elevati ta' enzimi epatiċi.
English: Step 1: Put on impermeable gloves.
Maltese: Pass 1: Ilbes ingwanti impermeabbli.
English: The veterinary medicinal product is applied topically to the inner pinna (inner surface of the ear) once daily for 14 days, at the dosage of 0.1 g ointment /cat (2 mg mirtazapine /cat).
Maltese: Il-prodott mediċinali veterinarju jiġi applikat b'mod topiku lill-pinna ta' ġewwa (superfiċje interna tal widna) darba kuljum għal 14-il jum, f'doża ta' 0.1 g ta' ingwent/qattus (2 mg ta' mirtazapine/qattus).
English: Do not use during pregnancy and lactation (see section 4.3).
Maltese: Tużax waqt it-tqala u t-treddigħ (ara s-sezzjoni 4.3).
English: <{MM/YYYY}> <{DD/MM/YYYY}> <{DD month YYYY}>
Maltese: Żomm fejn ma jidhirx u ma jintlaħaqx mit-tfal.
English: The recommended fixed dose has been tested in cats weighing between 2.1 kg and 7.0 kg
Maltese: Id-doża fissa rakkomandata ġiet ittestjata fi qtates li jiżnu bejn 2.1 kg u 7.0 kg
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 matul il-perjodu ta' kura waħda) - 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: 0.1 g contains 2 mg mirtazapine (as hemihydrate)
Maltese: 0.1 g fih 2 mg ta' mirtazapine (bħala hemihydrate)
English: Tube
Maltese: TAMMINISTRA
English: Step 1: Put on impermeable gloves
Maltese: Pass 1: Ilbes ingwanti impermeabbli
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Maltese: Ewropea dwar il-Mediċini (http://www.ema.europa.eu/).
English: Each dose of 0.1 g contains: Mirtazapine (as hemihydrate) 2 mg
Maltese: Kull doża ta' 0.1 g fiha: Mirtazapine (bħala hemihydrate) 2 mg
English: Inhibition of 5-HT2 and histamine H1 receptors may account for the orexigenic effects of the molecule.
Maltese: L-inibizzjoni tar-riċetturi 5-HT2 u tal-istamina H1 tista' tkun responsabbli mill effetti orossigeniċi tal-molekula.
English: The median accumulation between first and 35th dose was 3.71X (based on AUC ratio) and 3.90X (based on Cmax ratio).
Maltese: L-akkumulazzjoni medjana bejn l-ewwel u l-35 doża kienet ta' 3.71X (abbażi tal-proporzjon tal-AUC) u ta' 3.90X (abbażi talproporzjon tas-Cmax).
English: Transdermal ointment.
Maltese: Ingwent transdermali.
English: The known symptoms of a mirtazapine overdose of > 2.5 mg/kg in cats include: vocalization and behavioural changes, vomiting, ataxia, restlessness, and tremors.
Maltese: Is-sintomi magħrufa ta' doża eċċessiva b'mirtazapine ta' > 2.5 mg/kg fil-qtates jinkludu: tibdil filvokalizzazzjoni u fl-imġiba, rimettar, atassija, irrekwitezza, u rogħda.
English: After a single topical administration, the mean peak plasma concentration of 21.5 ng/ml (± 43.5) is reached in Tmax mean of 15.9 hours (1-48 hours).
Maltese: Wara għoti topiku uniku, ilkonċentrazzjoni massima medja fil-plażma ta' 21.5 ng/ml (± 43.5) tintlaħaq f'Tmax medja ta' 15.
English: Mirataz 20 mg/g transdermal ointment for cats mirtazapine
Maltese: Mirataz 20 mg/g ingwent transdermali għall-qtates mirtazapine
English: 5 gram coated aluminium tube (coat: lacquer (internal)/ enamel (external) with a low-density polyethylene (LDPE) screw cap and crimp sealant.
Maltese: Stoċċ tal-aluminju ta' 5 grammi miksi (kisi: laker (fuq ġewwa)/ enamel (fuq barra) b'tapp bil-kamin tal-polijetilin (LDPE) ta' densità baxxa u siġillant bil-pressa.
English: Mirtazapine is a potent antagonist of 5-HT2 and 5-HT3 receptors in the central nervous system (CNS), and a potent inhibitor of histamine H1 receptors.
Maltese: Mirtazapine huwa adrenolitiku b'saħħtu tar-riċetturi 5-HT2 u 5-HT3 fis-sistema nervuża ċentrali (CNS), u inibitur b'saħħtu tar riċevituri tal-istamina H1.
English: Mirtazapine is an α2-adrenergic receptor antagonist nor-adrenergic and serotonergic antidepressant drug.
Maltese: Mirtazapine huwa adrenolitiku noradrenerġiku ta' α2 u mediċina serotonerġika kontra d-dipressjoni.
English: After administration of the product to 8 cats at a dose of 0.5 mg/kg once daily for 14 days, mean peak plasma concentration of 39.6 ng/ml (± 9.72) is reached in Tmax mean of 2.13 hours (1-4 hours).
Maltese: Wara l-għoti tal-prodott lil tmint iqtates f'doża ta' 0.5 mg/kg darba kuljum għal 14-il jum, il-konċentrazzjoni massima medja fil-plażma ta' 39.6 ng/ml (± 9.72) tintlaħaq f'Tmax medja ta' 2.13 siegħa (1-4 sigħat).
English: Pharmacotherapeutic Group: Psychoanaleptics, antidepressants ATCvet code: QN06AX11
Maltese: Psikoanalettiċi, antidipressanti Kodiċi ATC veterinarja: QN06AX11 5.1 Kwalitajiet farmakodinamiċi Mirtazapine huwa adrenolitiku noradrenerġiku ta' α2 u mediċina serotonerġika kontra d-dipressjoni.
English: Transdermal ointment
Maltese: Il-Ġermanja
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Maltese: Biex tapplika l-prodott mediċinali veterinarju:
English: Vomiting, polyuria associated with reduced urine specific gravity, elevated blood urea nitrogen (BUN) and dehydration were commonly observed in safety and clinical studies.
Maltese: Rimettar, polijurja assoċjata ma' tnaqqis fil-gravità speċifika tal-awrina, żieda fin-nitroġenu tal-urea fiddemm (BUN) u deidratazzjoni ġew osservati b'mod komuni fi studji kliniċi u ta' sigurtà.