FrancophonIA/ELRC3.0 huggingface dataset:
English: Exposures in the ePPND study were approximately 32-fold greater than that noted at 300 mg q2 wks based on AUC.
Maltese: Lesponimenti fl-istudju ePPND kienu madwar 32 darba akbar minn dak innotat bi 300 mg q2 wks abbażi tal-AUC.
English: Each TAKHZYRO vial is intended for single use only (see section 6.6).
Maltese: Kull kunjett ta' TAKHZYRO huwa intenzjonat biex jintuża darba biss (ara sezzjoni 6.6).
English: All TAKHZYRO treatment groups observed an improvement in Angioedema Quality of Life Questionnaire (AE-QoL) total and domain (functioning, fatigue/mood, fear/shame, and nutrition) scores compared to the placebo group; the largest improvement was observed in the functioning score as shown in Table 4.
Maltese: Il-gruppi kollha ta' trattament b'TAKHZYRO osservaw titjib fil-punteġġi totali u tal-qasam (funzjonament, għeja/burdata, biża'/mistħija, u nutrizzjoni) tal-Kwestjonarju dwar il-Kwalità tal-Ħajja b'Anġjoedima (AE-QoL - Angioedema Quality of Life) meta mqabbla mal-grupp tal-plaċebo; l-akbar titjib ġie osservat fil-punteġġ ta' funzjonament kif muri fit-Tabella 4.
English: TAKHZYRO is available as a single pack containing one 2 ml vial and in multipacks comprising 2 or 6 cartons, each carton containing 1 vial.
Maltese: TAKHZYRO huwa disponibbli bħala pakkett wieħed li fih kunjett wieħed ta' 2 ml u f'pakketti multipli li jinkludu 2 jew 6 kartuniet, b'kull kartuna jkun fiha kunjett wieħed.
English: Solution for injection 1 vial of 2 ml component of a multipack, can't be sold separately.
Maltese: Soluzzjoni għall-injezzjoni Kunjett wieħed ta' 2 ml komponent ta' pakkett multiplu, ma jistax jinbiegħ separatament.
English: Results are from a Poisson regression model accounting for over dispersion with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and the logarithm of time in days each subject was observed during the treatment period as an offset variable in the model.
Maltese: Ir-riżultati huma minn mudell ta' rigressjoni Poisson li jikkunsidra dispersjoni żejda b'effetti fissi għall-grupp ta' trattament (kategoriċi) u rata ta' attakk normalizzata fil-linja bażi (kontinwi), u logaritmu taż-żmien f'jiem fejn kull individwu ġie osservat matul il-perjodu ta' trattament bħala varjabbli ta' kumpens fil-mudell.
English: This pack also contains: 3 ml syringe 18 gauge access needle Injection needle
Maltese: Kull pakkett wieħed fih ukoll: Siringa ta' 3 ml Labra ta' aċċess ta' 18 gauge Labra għall-injezzjoni
English: Secondary endpoint - Number of moderate or severe HAE attacks from Day 0 to 182 LS Mean (95% CI) monthly attack rate b
Maltese: Punt aħħari sekondarju - Numru ta' attakki ta' HAE moderati jew severi minn Jum 0 sa 182 Rata Medja LS ta' attakki fix-xahar (CI ta' 95%)
English: The most commonly (52.4%) observed adverse reaction associated with TAKHZYRO was injection site reactions (ISR) including injection site pain, injection site erythema and injection site bruising.
Maltese: Ir-reazzjoni avversa assoċjata ma' TAKHZYRO li ġiet osservata bl-aktar mod komuni (52.4%) kienet reazzjonijiet fis-sit tal-injezzjoni (ISR - injection site reactions) li jinkludu wġigħ fis-sit tal-injezzjoni, eritema fis-sit tal-injezzjoni u tbenġil fis-sit tal-injezzjoni.
English: Other medicines and TAKHZYRO
Maltese: Mediċini oħra u TAKHZYRO
English: The percentage of patients who were attack free for the last 16-weeks (Day 70 to Day 182) of the study was 77% in the 300 mg q2wks group, compared to 3% of patients in the placebo group.
Maltese: Il-perċentwali ta' pazjenti li ma kellhomx attakki matul l-aħħar 16-il ġimgħa (Jum 70 sa Jum 182) talistudju kien ta' 77% fil-grupp ta' 300 mg q2wks, meta mqabbel ma' 3% tal-pazjenti fil-grupp talplaċebo.
English: ANNEX III
Maltese: TAS-SUSTANZA/I
English: Common (may affect up to 1 in 10 people):
Maltese: Komuni (jistgħu jaffettwaw sa persuna waħda minn kull 10 persuni):
English: • genitals
Maltese: • fil-ġenitali
English: In repeat-dose studies evaluating once weekly SC injection in both rats (up to 28 days) and cynomolgus monkeys (up to 6 months) lanadelumab was well-tolerated at doses of up to and including 50 mg/kg (highest dose tested) with no organs of toxicity identified.
Maltese: Fi studji b'dożi ripetuti li jevalwaw injezzjoni SC darba fil-ġimgħa kemm fil-firien (sa 28 jum) kif ukoll fix-xadini tat-tip cynomolgus (sa 6 xhur) lanadelumab kien ittollerat tajjeb b'dożi sa u li jinkludu 50 mg/kg (l-ogħla doża ttestjata) mingħajr ma ġew identifikati organi ta' tossiċità.
English: Important: Inject TAKHZYRO within 2 hours of preparing the dosing syringe at room temperature.
Maltese: Injetta TAKHZYRO fi żmien sagħtejn mill-preparazzjoni tas-siringa taddożaġġ f'temperatura ambjentali.
English: • One empty 3 ml syringe.
Maltese: • Siringa waħda ta' 3 ml vojta.
English: TAKHZYRO may be self-administered or administered by a caregiver only after training on SC injection technique by a healthcare professional.
Maltese: TAKHZYRO jista' jingħata mill-pazjent stess jew jingħata minn persuna li tieħu ħsiebu biss wara taħriġ dwar it-teknika ta' injezzjoni SC minn professjonist tal-kura tas-saħħa.
English: Too much bradykinin leads to symptoms of HAE like swelling and pain on the,
Maltese: Bradykinin żejjed iwassal għal sintomi ta' HAE bħal nefħa u wġigħ,
English: Table 4 Change in AE-QoL score a
Maltese: Il-Kwalità tal-Ħajja relatata mas-Saħħa
English: TAKHZYRO should be administered within 2 hours of preparing the dosing syringe.
Maltese: TAKHZYRO għandu jingħata fi żmien sagħtejn mill-preparazzjoni tas-siringa tad-dożaġġ.
English: Exposures in cynomolgus monkeys following 6 months of administration were approximately 23-fold greater than that noted at 300 mg q2 wks based on AUC.
Maltese: L-esponimenti f'xadini tat-tip cynomolgus wara 6 xhur ta' għoti kienu madwar 23 darba akbar minn dak innotat bi 300 mg q2 wks abbażi tal-AUC.
English: Concentration-dependent inhibition of plasma kallikrein, measured as reduction of cHMWK levels, was demonstrated after SC administration of TAKHZYRO 150 mg every 4 weeks, 300 mg every 4 weeks or 300 mg every 2 weeks in subjects with HAE.
Maltese: Inibizzjoni ta' kallikrein fil-plażma li tiddependi mill-konċentrazzjoni, imkejla bħala tnaqqis tal-livelli ta' cHMWK, intweriet wara għoti SC ta' TAKHZYRO 150 mg kull 4 ġimgħat, 300 mg kull 4 ġimgħat jew 300 mg kull ġimagħtejn f'individwi b'HAE.
English: g) Screw the 27 gauge ½-inch (0.4 x 13 mm)
Maltese: g) Qabbad bil-kamin il-labra tal-injezzjoni bil-ponta ta' 27 gauge ½ pulzier (0.4 x 13 mm) massiringa.
English: How to use TAKHZYRO 4.
Maltese: Kif għandek tuża TAKHZYRO 4.
English: The mean (SD) volume of distribution of lanadelumab in patients with HAE is 14.5 litres (4.53).
Maltese: Il-volum medju (SD) ta' distribuzzjoni ta' lanadelumab f'pazjenti b'HAE huwa ta' 14.5 litri (4.53). Lanadelumab huwa antikorp monoklonali terapewtiku u mhux mistenni li jeħel mal-proteini filplażma.
English: As expected, concomitant use of the rescue medication C1 esterase inhibitor results in an additive effect on lanadelumab-cHMWK response based on the mechanism of action (MOA) of lanadelumab and C1 esterase inhibitor (see section 5.1).
Maltese: Kif mistenni, l-użu fl-istess waqt tal-inibitur ta' C1 esterase bħala medikazzjoni ta' salvataġġ jirriżulta f'effett addittiv fuq ir-rispons ta' lanadelumab-cHMWK abbażi tal-mekkaniżmu ta' azzjoni (MOAmechanism of action) ta' lanadelumab u tal-inibitur ta' C1 esterase (ara sezzjoni 5.1).
English: f) Place the 27 gauge ½-inch (0.4 x 13 mm)
Maltese: • Labra tal-għoti (injezzjoni) bil-ponta ta' 27 gauge ½ pulzier (0.4 x 13 mm).
English: TAKHZYRO is not intended for treatment of acute HAE attacks.
Maltese: TAKHZYRO mhuwiex maħsub għat-trattament ta' attakki akuti ta' HAE.
English: In a population pharmacokinetic analysis, after correcting for body weight, no influence of gender or age (12 to 75 years) was apparent on the clearance or volume of distribution of lanadelumab.
Maltese: F'analiżi tal-farmakokinetika tal-popolazzjoni, wara korrezzjoni għall-piż tal-ġisem, ma kinitx tidher influwenza tas-sess jew l-età (12 sa 75 sena) fuq it-tneħħija jew il-volum ta' distribuzzjoni ta' lanadelumab.
English: In the ePPND study in pregnant cynomolgus monkeys administered once weekly doses of 10 or 50 mg/kg (highest dose tested), there were no lanadelumab-related effects on pregnancy and parturition, embryo-foetal development, survival, growth, and/or postnatal development of offspring.
Maltese: Fl-istudju ePPND f'xadini tat-tip cynomolgus tqal mogħtija dożi darba fil-ġimgħa ta' 10 jew 50 mg/kg (l-ogħla doża ttestjata), ma kienx hemm effetti relatati ma' lanadelumab fuq it-tqala u l-ħlas, l-iżvilupp tal-embriju u tal-fetu, is-sopravivenza, it-tkabbir, u/jew l-iżvilupp wara t-twelid tal-wild.
English: The safety and efficacy of TAKHZYRO in children aged less than 12 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' TAKHZYRO fit-tfal taħt l-età ta' 12-il sena ma ġewx determinati s'issa.
English: The injection of TAKHZYRO can be summarised in 5 steps:
Maltese: L-injezzjoni ta' TAKHZYRO jista' jingħata fil-qosor f'5 passi:
English: Each vial contains 300 mg of lanadelumab in 2mL.
Maltese: Kull kunjett fih 300 mg ta' lanadelumab f'2 mL.
English: Inject TAKHZYRO subcutaneously into the abdomen, thigh, or upper arm (see section 4.2).
Maltese: Injetta TAKHZYRO taħt il-ġilda fiż-żaqq, fil-koxxa, jew fil-parti ta' fuq tad-driegħ (ara sezzjoni 4.2).
English: Pharmacokinetics of lanadelumab showed linear dose-exposure response with doses up to 400 mg and reproducible exposure following subcutaneous administration up to 12 months.
Maltese: Ilfarmakokinetika ta' lanadelumab uriet rispons lineari tal-esponiment għad-doża b'dożi sa 400 mg u esponiment riproduċibbli wara għoti taħt il-ġilda sa 12-il xahar.
English: • Dizziness, feeling faint
Maltese: Punteġġ tal-biża'/mistħija
English: 2 ml of solution in a vial (type I glass) with a coated butyl rubber stopper and an aluminium seal with violet flip-off cap.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih 2 ml ta' soluzzjoni f'kunjett (ħġieġ tat-tip I) b'tapp tal-lastku butyl miksi u siġill tal-aluminju b'għatu flip-off vjola.
English: EU/1/18/1340/001 EU/1/18/1340/002 EU/1/18/1340/003
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/18/1340/002
English: Following SC administration, the time to maximum concentration is approximately 5 days.
Maltese: Wara għoti SC, iż-żmien sal-konċentrazzjoni massima huwa ta' madwar 5 ijiem.
English: As IgG monoclonal antibodies are mainly eliminated via intracellular catabolism, renal impairment or hepatic impairment is not expected to influence clearance of lanadelumab.
Maltese: IgG huma eliminati prinċipalment permezz ta' kataboliżmu intraċellulari, indeboliment tal-kliewi jew indeboliment tal-fwied mhux mistenni li jinfluwenza ttneħħija ta' lanadelumab.
English: The mean reduction in HAE attack rate was consistently higher across the TAKHZYRO treatment arms compared to placebo regardless of the baseline history of LTP, laryngeal attacks, or attack rate during the run-in period.
Maltese: It-tnaqqis medju fir-rata ta' attakki ta' HAE kien ogħla b'mod konsistenti fil-gruppi ta' trattament b'TAKHZYRO meta mqabbla mal-plaċebo irrispettivament mill-passat ta' LTP fil-linja bażi, l-attakki fil-larinġi, jew ir-rata ta' attakki matul il-perjodu ta' tħejjija.
English: Lanadelumab had no effect on male or female fertility in cynomolgus monkeys (see section 5.3).
Maltese: Lanadelumab ma kellu l-ebda effett fuq il-fertilità tal-irġiel jew tan-nisa f'xadini tat-tip cynomolgus (ara sezzjoni 5.3).
English: • Reactions where the injection is given - symptoms include pain, skin redness, bruising, discomfort, swelling, bleeding, itching, hardening of skin, tingling, warmth and rash.
Maltese: • Reazzjonijiet fejn tingħata l-injezzjoni - is-sintomi jinkludu wġigħ, ħmura tal-ġilda, tbenġil, skumdità, nefħa, fsada, ħakk, ebusija tal-ġilda, tnemnim, sħana u raxx.
English: Be sure that you read, understand and follow the step-by-step instructions for injecting TAKHZYRO.
Maltese: Kun ċert li taqra, tifhem u ssegwi pass wara pass l-istruzzjonijiet għall-injezzjoni ta' TAKHZYRO.
English: Step 5: Inject TAKHZYRO
Maltese: Kemm għandek tuża TAKHZYRO
English: B. PACKAGE LEAFLET
Maltese: Pakkett multiplu:
English: There is limited information on the safety of TAKHZYRO use during pregnancy and breast-feeding.
Maltese: Hemm informazzjoni limitata dwar issigurtà tal-użu ta' Takhzryo waqt it-tqala u t-treddigħ.
English: No dose adjustment is required in patients with hepatic impairment (see section 5.2).
Maltese: Mhux meħtieġ aġġustament fid-doża f'pazjenti b'indeboliment tal-fwied (ara sezzjoni 5.2).
English: • Allergic reactions including itching, discomfort and tingling of the tongue
Maltese: • Reazzjonijiet allerġiċi li jinkludu ħakk, skumdità u tnemnim tal-ilsien
English: The single and multiple dose pharmacokinetics of lanadelumab have been studied in patients with HAE.
Maltese: Il-farmakokinetika ta' doża waħda u dożi multipli ta' lanadelumab ġiet studjata f'pazjenti b'HAE.
English: Age is not expected to affect exposure to lanadelumab.
Maltese: L-età mhijiex mistennija li taffettwa l-esponiment għal lanadelumab.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIRRIGWARD TAL-UŻU SIGUR U EFFETTIV TALPRODOTT MEDIĊINALI
English: Avoid vigorous agitation.
Maltese: Evita li tħawwad bis-saħħa.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with TAKHZYRO in one or more subsets of the paediatric population in the prevention of hereditary angioedema attacks.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddifferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji b'TAKHZYRO f'wieħed jew aktar kategoriji tal-popolazzjoni pedjatrika fil-prevenzjoni ta' attakki ta' anġjoedima ereditarja.
English: Attach blunt tip vial access needle to syringe 3.
Maltese: X'għandek tkun taf qabel ma tuża TAKHZYRO 3.
English: Using aseptic technique, withdraw the prescribed dose of TAKHZYRO from the vial into the syringe using an 18 gauge needle.
Maltese: Bl-użu ta' teknika asettika, iġbed id-doża preskritta ta' TAKHZYRO mill-kunjett għal ġos-siringa blużu ta' labra ta' 18 gauge.
English: TAKHZYRO 300 mg solution for injection lanadelumab This medicine is subject to additional monitoring.
Maltese: Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: If not administered immediately after preparation, the syringe may be stored in the refrigerator (2C to 8C), protected from light and administered within 8 hours.
Maltese: Jekk ma jingħatax immedjatament wara l-preparazzjoni, is-siringa tista' tinħażen fil-friġġ (2C sa 8C), protetta mid-dawl u trid tingħata fi żmien 8 sigħat.
English: Fatigue/Mood score
Maltese: BIJOLOĠIKA/ĊI ATTIVA/I
English: • One 27 gauge ½-inch (0.4 x 13 mm) pointed tip injection needle.
Maltese: 27 gauge ½ pulzier (0.4 x 13 mm) u s-siringa f'kontenitur għar-rimi ta' oġġetti li jaqtgħu u bilponta.
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 updates of the RMP.
Maltese: • Pjan tal-Ġestjoni tar-Riskju (RMP) L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza ddettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-awtorizzazzjoni għat-tqegħid fis-suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: The anticipated time to reach steady state concentration was approximately 70 days.
Maltese: Iż-żmien antiċipat sakemm tintlaħaq konċentrazzjoni fi stat fiss kien ta' madwar 70 jum.
English: If you inject TAKHZYRO yourself or if your caregiver injects it, you or your caregiver must carefully read and follow the instructions in section 7, “Instructions for use”.
Maltese: Jekk tinjetta TAKHZYRO inti stess jew jekk tinjettahulek persuna li tieħu ħsiebek, inti jew din il-persuna tridu taqraw u ssegwu bir-reqqa l-istruzzjonijiet fis-sezzjoni 7, “Istruzzjonijiet għallużu”.
English: Model-based treatment period HAE attack rate (attacks/4 weeks).
Maltese: Rata ta' attakki ta' HAE fil-perjodu ta' trattament ibbażat fuq il-mudell (attakki/4 ġimgħat).
English: • Inject the medicine in a different place each time.
Maltese: • Injetta l-mediċina f'post differenti kull darba.
English: 20 October 2011
Maltese: 20 ta' Ottubru 2011
English: International non-proprietary name (inn): amoxicillin trihydrate, potassium clavulanate, prednisolone
Maltese: Isem ġeneriku internazzjonali (inn): amoxicillin trihydrate, potassium clavulanate, prednisolone
English: Prednisolone is an anti-inflammatory corticosteroid.
Maltese: Prednisolone huwa kortikosterojde anti-infjammatorju.
English: This combination is effective against β-lactamase producing organisms.
Maltese: Din il-kombinazzjoni hija effettiva kontra organiżmi li jipproduċu β-lactamase.
English: Oral explanations were given on 4 May 2011.
Maltese: Spjegazjonijiet orali ingħataw fl4 ta' Mejju 2011.
English: Synulox Lactating Cow and associated names is a 3 g pale cream/buff coloured oily suspension presented in disposable intramammary syringes containing 200 mg amoxicillin as amoxicillin trihydrate, 50 mg clavulanic acid as potassium clavulanate and 10 mg prednisolone.
Maltese: Synulox Lactating Cow u l-ismijiet assoċjati huma sospensjoni żejtnija ta' lewn krema ċar/isfar skur ta' 3 g ippreżentati bħala siringi intramammarji li jintremew wara l-użu li fihom 200 mg amoxicillin bħala amoxicillin trihydrate, 50 mg clavulanic acid bħala potassium clavulanate u 10 mg prednisolone.
English: The Committee appointed Dr Bruno Urbain as rapporteur and Mrs Ruth Kearsley as co-rapporteur.
Maltese: Il-Kumitat ħatar lil Dr Bruno Urbain bħala rapporteur u lis-Sinjura Ruth Kearsley bħala l-ko-rapporteur.
English: Clavulanic acid inactivates β-lactamases.
Maltese: Clavulanic acid jidiżattiva βlactamases.
English: Due to the divergent national decisions taken by Member States concerning the authorisation of Synulox Lactating Cow and associated names and differences between the summary of product characteristics (SPC) of the product as authorised in the Member States, the issue was referred on 26 March 2010 by Belgium and Denmark to the CVMP under Article 34(1) of Directive 2001/82/EC.
Maltese: Minħabba d-deċiżjonijiet nazzjonali diverġenti li ttieħdu mill-Istati Membri dwar l-awtorizzazzjoni ta' Synulox Lactating Cows u l-ismijiet assoċjati u d-differenzi bejn is-sommarju tal-karatteristiċi talprodott (SPC) kif awtorizzati fl-Istati Membri, fis-26 ta' Marzu 2010 il-Belġju u d-Danimarka rriferew ilkwistjoni lis-CVMP skont l-Artikolu 34(1) tad-Direttiva 2001/82/KE.
English: Opinion following an Article 34 referral for Synulox Lactating Cow and associated names
Maltese: Opinjoni wara riferiment skont l-Artikolu 34 għal Synulox Lactating Cow u l-ismijiet assoċjati
English: The final opinion was converted into a Decision by the European Commission on 20 October 2011.
Maltese: L-opinjoni finali ġiet ikkonvertita f'Deċiżjoni mill-Kummissjoni Ewropea fi 20 ta' Ottubru 2011.
English: Written explanations were provided by the marketing authorisation holders on 18 August 2010 and 8 February 2011.
Maltese: tqegħid fis-suq fit-18 ta' Awwissu 2010 u fit-8 ta' Frar 2011.
English: Further to the resignation of Mrs Ruth Kearsley as CVMP member, Ms Helen Jukes was appointed to replace her and took over the co-rapporteurship.
Maltese: Wara r-riżenja tas-Sinjura Ruth Kearsley bħala membru tas-CVMP, is-Sinjura Helen Jukes inħatret biex tieħu postha u ħadet f'idejha l-irwol ta' ko-rapporteur.
English: The reason for divergent national decisions regarding the authorisation of the products was mainly the justification of the combination of amoxicillin/clavulanic acid/prednisolone for the treatment of bovine mastitis.
Maltese: Ir-raġuni għad-deċiżjonijiet nazzjonali diverġenti dwar l-awtorizzazzjoni tal-prodotti kienet prinċipalment il-ġustifikazzjoni tal-kombinazzjoni ta' amoxicilline/clavulanic acid /prednisolone fil-kura ta' mastite fil-bovini.
English: Veterinary Medicines and Product Data Management
Maltese: Mediċini Veterinarji u Ġestjoni tad-Data tal-Prodott
English: The referral procedure started on 14 April 2010.
Maltese: Il-proċedura ta' riferiment bdiet fl-14 ta' April 2010.
English: The product is intended for the treatment of bovine clinical mastitis in lactating cows.
Maltese: Il-prodott huwa maħsub għall-kura ta' mastite klinika fil-bovini f'baqar li qegħdin ireddgħu.
English: Amoxicillin is a broad spectrum bactericidal β-lactam antibiotic.
Maltese: Amoxicillin huwa antibijotiku β-lactam batteriċida bi spettru wiesgħa.
English: Other information about Acticam:
Maltese: Informazzjoni oħra dwar Acticam:
English: Acticam is a ‘generic': this means that Acticam is similar to a ‘reference veterinary medicine' already authorised in the EU (Metacam 1.5 mg/ml oral suspension).
Maltese: Acticam huwa ‘ġeneriku': dan ifisser li Acticam huwa simili għal ‘mediċina veterinarja ta' referenza' li hija diġà awtorizzata fl-UE (Metacam 1.5 mg/ml ta' sospensjoni orali).
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Acticam on 9 December 2008.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea għal Acticam fid-9 ta' Diċembru 2008.
English: What is the risk associated with Acticam?
Maltese: X'inhu r-riskju assoċjat ma' Acticam?
English: What is Acticam?
Maltese: X'inhu Acticam?
English: If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk tixtieq iktar informazzjoni relatata marrakkomandazzjonijiet tas-CVMP, aqra d-Diskussjoni Xjentifika (ukoll parti mill-EPAR).
English: The CVMP concluded that the benefits of Acticam exceed the risks for the alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders, reduction of post-operative pain and inflammation following orthopaedic and soft tissue surgery in dogs and reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery in cats and recommended that Acticam be given a marketing authorisation.
Maltese: Is-CVMP ikkonkluda li l-benefiċċji ta' Acticam huma akbar mir-riskji tiegħu fit-taffija ta' infjammazzjoni u uġigħ f'mard muskuloskeletriku tat-tip akut kif ukoll kroniku, fit-tnaqqis ta' uġigħ u infjammazzjoni ta' wara operazzjoni wara kirurġija ortopedika u tat-tessut artab fil-klieb u fittnaqqis ta' uġigħ ta' wara operazzjoni wara kirurġija fejn jitneħħew l-ovarji u l-utru u kirurġija minuri tat-tessut artab fil-qtates u rrakkomanda li Acticam jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: In very rare cases, they may be serious or fatal.
Maltese: F'każijiet verament rari, jistgħu jkunu serji jew fatali.
English: Acticam contains meloxicam which belongs to a class of medicines having anti-inflammatory action.
Maltese: Acticam fih meloxicam li jappartjeni għal klassi ta' mediċini li jaġixxu kontra l-infjammazzjoni.
English: Occasional side effects of Acticam are those seen with NSAIDs, such as loss of appetite, vomiting, diarrhoea, blood appearing in the stools and apathy (lack of vitality).
Maltese: Effetti sekondarji mhux regolari ta' Acticam huma dawk li jidhru bl-NSAIDs, bħat-telf ta' aptit, rimetter, dijarrea, demm fil-feċi u apatija (nuqqas ta' vitalità).
English: Acticam is presented as an oral suspension 1.5 mg/ml for dogs (to be given mixed with food) and a solution for injection 5mg/ml.
Maltese: Acticam jiġi bħala sospensjoni orali ta' 1.5 mg/ml għall-klieb (li għandu jingħata mħallat mal-ikel) u soluzzjoni ta' 5 mg/ml għall-injezzjoni.
English: Why has Acticam been approved?
Maltese: Għaliex ġie approvat Acticam?
English: How has Acticam been studied?
Maltese: Kif ġie studjat Acticam?