FrancophonIA/ELRC3.0 huggingface dataset:
English: The plasma elimination half-life of benazepril hydrochloride and benazeprilat, when dosed with FORTEKOR PLUS tablets is 0.36 h and 8.36 h, respectively.
Maltese: Il-half-life tal-eliminazzjoni mill-plażma ta' benazepril hydrochloride u benazeprilat, meta jingħataw bilpilloli FORTEKOR PLUS, hija ta' 0.36 h u 8.36 h, rispettivament.
English: Over 40 kg
Maltese: 'Il fuq minn 40 kg
English: Microcrystalline cellulose
Maltese: Microcrystalline cellulose Polysorbate 80
English: FORTEKOR PLUS 5 mg/10 mg tablets
Maltese: FORTEKOR PLUS 5 mg/10 mg pilloli
English: FORTEKOR PLUS 1.25 mg/2.5 mg tablets
Maltese: FORTEKOR PLUS 1.25 mg/2.5 mg pilloli
English: After the oral administration of FORTEKOR PLUS tablets at twice the recommended dose to dogs, peak levels of both compounds are attained rapidly (Tmax 0.5 h for benazepril hydrochloride and 0.85 h for pimobendan) with peak concentrations (Cmax) for benazepril hydrochloride of 35.1 ng/ml and 16.5 ng/ml for pimobendan.
Maltese: Wara l-għoti b'mod orali, tal-pilloli FORTEKOR PLUS bid-doppju tad-doża rakkomandata lill-klieb, il livelli massimi taż-żewġ komposti jinkisbu malajr (Tmax 0.5 h għal benazepril hydrochloride u 0.85 h għal pimobendan) b'konċentrazzjonijiet massimi (Cmax) għal benazepril hydrochloride ta' 35.1 ng/ml u 16.5ng/ml għal pimobendan.
English: Each tablet contains 5 mg pimobendan and 10 mg benazepril hydrochloride.
Maltese: Kull pillola fiha 5 mg pimobendan u 10 mg benazepril hydrochloride.
English: Peak benazeprilat levels are seen after 1.9 h with peak concentrations (Cmax) of 43.4 ng/ml.
Maltese: Il-livelli massimi ta' benazeprilat jidhru wara 1.9 h b'konċentrazzjonijiet massimi (Cmax) ta' 43.4 ng/ml.
English: Do not use during pregnancy and lactation (see section 4.7).
Maltese: Tużax waqt it-tqala u t-treddigħ (ara sezzjoni 4.7).
English: The pimobendan-induced increase in contractility of the heart is attenuated in the presence of the calcium antagonist verapamil and the ß-antagonist propranolol.
Maltese: Iż-żieda fil-kontrattilità tal-qalb, ikkawżata minn pimobendan, titnaqqas fil-preżenza tal antagonist tal-kalċju, verapamil, u l-antagonist-ß, propranolol.
English: Benazepril and benazeprilat are extensively bound to plasma proteins (8590%), and in the tissues they are found mainly in the lung, liver and kidney.
Maltese: Benazepril u benazeprilat jeħlu b'mod estensiv mal-proteini tal-plażma (85-90%), u fit-tessuti jinstabu prinċipalment fil-pulmun, filfwied u fil-kliewi.
English: 4.6 Adverse reactions (frequency and seriousness)
Maltese: 4.6 Effetti mhux mixtieqa (frekwenza u gravità) Pimobendan
English: FORTEKOR PLUS 5 mg/10 mg tablets: 30 tablets or 60 tablets.
Maltese: FORTEKOR PLUS 5 mg/10 mg pilloli: 30 pillola jew 60 pillola.
English: FORTEKOR PLUS 1.25 mg/2.5 mg tablets: 30 tablets or 60 tablets.
Maltese: FORTEKOR PLUS 1.25 mg/2.5 mg pilloli: 30 pillola jew 60 pillola.
English: Benazepril hydrochloride is a prodrug hydrolysed in vivo to its active metabolite, benazeprilat.
Maltese: Benazepril hydrochloride huwa prodrug idrolizzata in vivo għall-metabolit attiv tagħha, benazeprilat.
English: Benazeprilat concentrations decline biphasically: the initial fast phase (t1/2 = 1.7 h) represents elimination of the free drug, while the terminal phase (t1/2 = 19 h) reflects the release of benazeprilat that was bound to ACE, mainly in the tissues.
Maltese: Il-konċentrazzjonijiet ta' benazeprilat jonqsu f'żewġ fażijiet: il-fażi inizjali mgħaġġla (t1/2 = 1.7 h) tirrappreżenta l-eliminazzjoni tal-mediċina libera, filwaqt li l-fażi terminali (t1/2 = 19 h), tirrappreżenta rrilaxx ta' benazeprilat li kien imwaħħal mal-ACE, prinċipalment fit-tessuti.
English: In pharmacological studies no interaction between the cardiac glycoside ouabain and pimobendan was detected.
Maltese: Fi studji farmakoloġiċi ma kienet innotata l-ebda interazzjoni bejn il-glikoside ouabain tal-qalb u pimobendan.
English: After oral administration of benazepril hydrochloride alone, the systemic bioavailability is incomplete (~13%) in dogs due to incomplete absorption (38%) and first pass metabolism.
Maltese: Wara l-għoti b'mod orali, ta' benazepril hydrochloride waħdu, il-bijodisponibilità sistemika ma tkunx kompleta (~13%) fil-klieb minħabba assorbiment inkomplet (38%) u l-metaboliżmu tal-ewwel passaġġ.
English: The combination of FORTEKOR PLUS and other anti-hypertensive agents (e.g. calcium channel blockers, β-blockers or diuretics), anaesthetics or sedatives may lead to additive hypotensive effects.
Maltese: Il-kombinazzjoni ta' FORTEKOR PLUS u sustanzi oħra kontra l-pressjoni għolja (eż. l-imblokkaturi tal-kanali tal-kalċju, βimblokkaturi jew dijuretiċi), anestetiċi jew sedattivi, tista' twassal għal effetti ipotensivi addittivi.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Maltese: 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: NAME OF THE VETERINARY MEDICINAL PRODUCT FORTEKOR PLUS 1.25 mg/2.5 mg tablets for dogs FORTEKOR PLUS 5 mg/10 mg tablets for dogs pimobendan/benazepril hydrochloride
Maltese: VETERINARJU FORTEKOR PLUS 1.25 mg/2.5 mg pilloli għall-klieb FORTEKOR PLUS 5 mg/10 mg pilloli għall-klieb pimobendan/benazepril hydrochloride
English: It increases the calcium sensitivity of cardiac myofilaments and inhibits phosphodiesterase (type III).
Maltese: Huwa jżid is sensittività għall-kalċju, tal-mijofilamenti tal-qalb u jinibixxi l-phosphodiesterase (tip III).
English: The volume of distribution at steady state is 2.6 l/kg after intravenous administration of pimobendan alone, indicating that pimobendan is distributed readily into the tissues.
Maltese: Il-volum tad-distribuzzjoni fiss huwa ta' 2.6 l/kg wara għoti mill-vina ta' pimobendan waħdu, li jindika li pimobendan jiġi distribwit faċilment fit-tessuti.
English: The plasma elimination half-life of pimobendan when dosed with FORTEKOR PLUS tablets is 0.5 h, consistent with the high clearance of the compound.
Maltese: Il-half-life tal-eliminazzjoni mill-plażma ta' pimobendan, meta jingħata bil-pilloli FORTEKOR PLUS hija ta' 0.5 h, konsistenti mat-tneħħija għolja tal-kompost.
English: In man, the combination of angiotensin converting enzyme (ACE) inhibitors and non-steroidal antiinflammatory drugs (NSAIDs) can lead to reduced anti-hypertensive efficacy or impaired renal function.
Maltese: Fl-irġiel, il-kombinazzjoni ta' inibituri tal-enzima li tikkonverti l-anġjotensina (ACE) u mediċini antiinfjammatorji mhux sterojdi (NSAIDs) tista' twassal għal tnaqqis fl-effikaċja kontra l-pressjoni għolja jew għal indeboliment fil-funzjoni tal-kliewi.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each tablet contains 1.25 mg pimobendan and 2.5 mg benazepril hydrochloride.
Maltese: Kull pillola fiha 1.25 mg pimobendan u 2.5 mg benazepril hydrochloride.
English: Pack Sizes
Maltese: Daqsijiet tal-Pakkett
English: Repeated administration of benazepril hydrochloride leads to slight bioaccumulation of benazeprilat (R = 1.47), steady state being achieved within a few days (4 days).
Maltese: L-għoti ripetut ta' benazepril hydrochloride jwassal għal bijoakkumulazzjoni żgħira ta' benazeprilat (R = 1.47), bl-istat fiss jinkiseb fi żmien ftit jiem (4 ijiem).
English: Laboratory studies in rats with benazepril have shown foetotoxic effects (foetal urinary tract malformation) at maternally non-toxic doses.
Maltese: Studji fil-laboratorju fil-firien b'benazepril urew effetti tossiċi fuq il-fetu (malformazzjoni tal-apparat urinarju tal-fetu) b'dożi li ma kinux tossiċi għall-omm.
English: Interactions with potassium-preserving diuretics like spironolactone, triamterene or amiloride cannot be ruled out.
Maltese: Ma jistgħux jiġu esklużi interazzjonijiet ma' dijuretiċi li jżommu l-potassju fil-ġisem bħal spironolactone, triamterene jew amiloride.
English: In dogs with congestive heart failure, benazepril hydrochloride and pimobendan have been given in combination with digoxin and diuretics without demonstrable adverse interactions.
Maltese: Fi klieb b'insuffiċjenza konġestiva tal-qalb, benazepril hydrochloride u pimobendan ingħataw flimkien ma' digoxin u dijuretiċi mingħajr interazzjonijiet avversi evidenti.
English: Benazepril hydrochloride is partially metabolised by liver enzymes to the active metabolite benazeprilat.
Maltese: Benazepril hydrochloride jiġi metabolizzat b'mod parzjali mill-enzimi tal-fwied fil-metabolit attiv tiegħu benazeprilat.
English: The main active metabolite of pimobendan is eliminated with a plasma elimination half-life of 2.6 h. Pimobendan is excreted principally in the faeces and to a lesser extent in the urine.
Maltese: Il-metabolit attiv prinċipali ta' pimobendan jiġi eleminat b'half-life tal-eliminazzjoni mill-plażma ta' 2.6 h.
English: Do not use in case of hypersensitivity to pimobendan, to benazepril hydrochloride or to any ingredient of the tablets.
Maltese: Tużax f'każijiet ta' sensittività eċċessiva għal pimobendan, għal benazepril hydrochloride jew għal kwalunkwe ingredjent ieħor tal-pilloli.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary In case of overdose the dog should be treated symptomatically.
Maltese: 4.10 Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti), jekk ikun hemm bżonn
English: NAME OF THE VETERINARY MEDICINAL PRODUCT FORTEKOR PLUS 1.25 mg/2.5 mg tablets for dogs FORTEKOR PLUS 5 mg/10 mg tablets for dogs
Maltese: VETERINARJU FORTEKOR PLUS 1.25 mg/2.5 mg pilloli għall-klieb FORTEKOR PLUS 5 mg/10 mg pilloli għall-klieb
English: The recommended dose range for FORTEKOR PLUS is 0.25-0.5 mg pimobendan per kg bodyweight and 0.5-1 mg benazepril hydrochloride per kg bodyweight divided into two daily doses.
Maltese: Il-medda tad-doża rakkomandata għal FORTEKOR PLUS hija 0.25-0.5 mg pimobendan għal kull kg tal-piż tal-ġisem u 0.5-1 mg benazepril hydrochloride għal kull kg tal-piż tal-ġisem, maqsuma f'żewġ dożi kuljum.
English: People with known hypersensitivity to pimobendan or benazepril hydrochloride should avoid contact with the veterinary medicinal product.
Maltese: Nies li huma sensittivi għal pimobendan jew benazepril hydrochloride għandhom jevitaw li jmissu malprodott mediċinali veterinarju.
English: Further metabolic pathways are phase II, glucuronides and sulfates.
Maltese: Rotot metaboliċi oħra huma l-glukuronidi u s-sulfati ta' fażi
English: In rare cases transient diarrhoea, anorexia or lethargy may be observed.
Maltese: F'każijiet rari, jistgħu jkunu osservati dijarea, anoressija jew letarġija għaddiena.
English: In cases of chronic kidney disease, it is recommended to check the hydration status before starting therapy, and to monitor plasma creatinine and blood erythrocyte counts during therapy.
Maltese: F'każijiet ta' mard kroniku tal-kliewi, huwa rakkomandat li jiġi ċċekkjat l-istat ta' idratazzjoni qabel ma tinbeda t-terapija, u li jiġi mmonitorjat l-għadd tal-kreatinina fil-plażma u tal-eritroċiti fid-demm matul it-terapija.
English: In rare cases transient diarrhoea, anorexia or lethargy have been observed.
Maltese: F'każijiet rari, kienu osservati dijarea, anoressija jew letarġija għaddiena.
English: Do not use in cases of hypotension, hypovolaemia, hyponatraemia or acute renal failure.
Maltese: Tużax f'każijiet ta' pressjoni baxxa, ipovolimja, iponatrimija jew insuffiċjenza renali akuta.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Elanco GmbHHeinz-Lohmann-Str. 4
Maltese: Dawn il-miżuri għandhom jgħinu sabiex jipproteġu l-ambjent.
English: Pimobendan:
Maltese: EFFETTI MHUX MIXTIEQA Pimobendan:
English: Levels of benazepril decline quickly as the drug is partially metabolised by liver enzymes to benazeprilat.
Maltese: Il livelli ta' benazepril jonqsu malajr hekk kif il-mediċina tiġi metabolizzata parzjalment mill-enzimi talfwied f'benazeprilat.
English: Pharmacodynamic properties
Maltese: IEĦOR Proprjetajiet farmakodinamiċi
English: The clearance of benazeprilat is not affected in dogs with impaired renal function; therefore no adjustment of the FORTEKOR PLUS dose is required in dogs with renal insufficiency.
Maltese: It-tneħħija ta' benazeprilat mhijiex affettwata fi klieb b'indeboliment tal-funzjoni renali; għalhekk ma huwa meħtieġ l-ebda aġġustament fid-doża ta' FORTEKOR PLUS fi klieb b'insuffiċjenza renali.
English: Dogs
Maltese: Folja
English: A moderate increase in plasma creatinine concentrations following administration of ACE inhibitors is compatible with the reduction in glomerular hypertension induced by these agents, and is therefore not necessarily a reason to stop therapy in the absence of other signs.
Maltese: Żieda moderata fil-konċentrazzjonijiet tal-kreatinina fil-plażma wara l-għoti ta' inibituri tal-ACE hija kompatibbli mat-tnaqqis fil-pressjoni għolja glomerulari kkawżat minn dawn is-sustanzi, u għalhekk mhux neċessarjament hija raġuni sabiex titwaqqaf it-terapija fin-nuqqas ta' sinjali oħra.
English: Elanco GmbH
Maltese: Elanco
English: Benazepril increased the time to worsening of heart failure, and the time to death, improved clinical condition, reduced cough and improved exercise tolerance in dogs with symptomatic congestive heart failure caused by valvular disease or dilated cardiomyopathy.
Maltese: Benazepril tawwal iż-żmien sat-taħżin tal-insuffiċjenza tal-qalb, u żżmien sal-mewt, tejjeb il-kundizzjoni klinika, naqqas is-sogħla u tejjeb it-tolleranza għall-eżerċizzju fi klieb b'insuffiċjenza konġestiva tal-qalb sintomatika kkawżata minn mard valvulari jew kardjomijopatija dilatata.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains:
Maltese: Interazzjonijiet ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni:
English: Laboratory studies in rats have shown that pimobendan is excreted into milk.
Maltese: Studji fil-laboratorju fil-firien urew li pimobendan jiġi eliminat fil-ħalib.
English: Your veterinary surgeon may recommend to closely monitor kidney function and for signs of hypotension (lethargy, weakness etc) and treat these if necessary.
Maltese: Il-kirurgu veterinarju tiegħek jista' jirrakkomanda monitoraġġ mill-qrib tal funzjoni tal-kliewi u għal sinjali ta' pressjoni baxxa (letarġija, dgħufija, eċċ.) u kura għal dawn jekk ikun meħtieġ.
English: Note:
Maltese: Attenzjoni:
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Maltese: Sussegwentement l-informazzjoni tal-prodott tista' tiġi aġġornata mill-awtoritajiet kompetenti tal-Istati Membri, flimkien mal-Istat Membru ta' Referenza, kif xieraq, skont il-proċeduri stabbiliti fil-Kapitolu 4 tat-Titolu III tad-Direttiva 2001/83/KE.
English: Established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
Maltese: Insuffiċjenza konġestiva tal-qalb stabbilita (NYHA II-IV), mard iskemiku tal-qalb, mard tal-arterji periferali u/jew mard ċerebrovaskulari.
English: Section 4.8 Undesirable effects: [The wording below should be inserted in this section]
Maltese: Sezzjoni 4.8 Effetti mhux mixtieqa [Is-sentenza li ġejja għandha tiddaħħal f'din it-taqsima]
English: Clinical trial and epidemiological data consistently point towards an increased risk of arterial thrombotic events (for example myocardial infarction or stroke) associated with the use of diclofenac, particularly at high dose (150mg daily) and in long term treatment.
Maltese: Dejta epidemjoloġika u mill-provi kliniċi l-ħin kollu juru żieda fir-riskju ta' episodji trombotiċi arterjali (bħal ngħidu aħna infart mijokardijaku jew puplesija) b'rabta ma' l-użu ta' diclofenac, b'mod partikulari meta jingħataw dożi għoljin (150mg kuljum) u meta t-trattament jingħata fit-tul (ara sezzjoni 4.3 u 4.4 għal Kontraindikazzjonijiet u Twissijiet speċjali u prekawzjonijiet għall-użu).
English: B. Package Leaflet
Maltese: Sezzjoni 4.4
English: (see section 4.3 and 4.4 for Contraindications and Special warnings and special precautions for use).
Maltese: Sezzjoni 4.3 Kontraindikazzjonijiet:
English: Do not use diclofenac if you have established heart disease and /or cerebrovascular disease e.g. if you have had a heart attack, stroke, mini-stroke (TIA) or blockages to blood vessels to the heart or brain or an operation to clear or bypass blockages if you have or have had problems with your blood circulation (peripheral arterial disease)
Maltese: Tużax diclofenac jekk għandek mard tal-qalb stabbilit u/jew mard ċerebrovaskulari eż. jekk kellek attakk talqalb, puplesija, puplesija ħafifa (TIA) jew arterji u vini li jwasslu d-demm lill-qalb jew 'il-moħħ imblukkati jew operazzjoni biex jitneħħa dan l-imblokk jew biex isir bajpass jekk għandek jew kellek problemi b'rabta maċ-ċirkulazzjoni tad-demm tiegħek (mard arterjali periferali)
English: Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with diclofenac after careful consideration.
Maltese: Pazjenti b'fatturi ta' riskju sinifikanti għal episodji kardjovaskulari (eż. pressjoni għolja, iperlipidimja, dijabete mellitus, tipjip) għandhom ikunu ttrattati b'diclofenac wara li jsirilhom eżami xieraq.
English: A. Summary of Product Characteristics Section 4.2 Posology and method of administration: [The wording below should be inserted in this section]
Maltese: Sommarju tal-Karatteristiċi tal-Prodott Sezzjoni 4.2 Pożoloġija u metodu ta' kif għandu jingħata:
English: Section 2 ‘What you need to know before you take <diclofenac containing medicinal product> [The wording below should be inserted in the relevant sections]
Maltese: Sezzjoni 2 ‘X'għandek tkun taf qabel ma tieħu <prodott mediċinali li fih diclofenac>' [Is-sentenzi li ġejjin għandhom jiddaħħlu f'din it-taqsima]
English: 1 vial
Maltese: 1 Kunjett
English: Strength Pharmaceutical
Maltese: Qawwa Għamla farmaċewtika
English: 23 May 2014 EMA/232003/2014 EMEA/H/C/000560 EMEA/H/C/000561
Maltese: EMEA/H/C/000560 EMEA/H/C/000561
English: The full European Public Assessment Report for Protelos/Osseor can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: What is Protelos/Osseor?
Maltese: X'inhu Protelos/Osseor?
English: Protelos/Osseor has been authorised since September 2004.
Maltese: Protelos/Osseor ilu awtorizzat minn Settembru 2004.
English: The applicant presented data from one main study involving 1,683 patients with osteoarthritis of the knee.
Maltese: L-applikant ippreżenta dejta minn studju ewlieni wieħed li involva 1,683 pazjent b'osteoartrite flirkoppa.
English: In this study, strontium ranelate 1 or 2 g was compared with placebo (a dummy treatment).
Maltese: F'dan l-istudju, strontium ranelate 1 jew 2 g tqabbel ma' plaċebo (trattament finta).
English: Protelos and Osseor are identical medicines that contain the active substance strontium ranelate.
Maltese: Protelos u Osseor huma mediċini identiċi li fihom is-sustanza attiva strontium ranelate.
English: On 21 March 2014, Les Laboratoires Servier officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its applications to extend the indication of Protelos/Osseor to include the treatment of osteoarthritis of the knee and hip.
Maltese: Fil-21 ta' Marzu 2014, Les Laboratoires Servier għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċnali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni li tirtira l-applikazzjonijiet tagħha għallestensjoni tal-indikazzjoni ta' Protelos/Osseor biex tinkludi kura ta' osteoartrite tal-irkoppa u talġenbejn.
English: The applications were withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Maltese: L-applikazzjonijiet ġew irtirati wara li s-CHMP kien evalwa d-dokumentazzjoni pprovduta millkumpanija u fformula lista ta' mistoqsijiet.
English: Strontium ranelate, the active substance in Protelos/Osseor, is expected to stimulate formation of new cartilage and reduce bone breakdown.
Maltese: Strontium ranelate, is-sustanza attiva fi Protelos/Osseor, huwa mistenni li jistimula formazzjoni ta' kartilaġni ġdid u jnaqqas it-tkissir tal-għadam.
English: They are available as sachets containing strontium ranelate (2 g) as granules to be made up into a suspension to be taken by mouth.
Maltese: Jiġu bħala qratas li fihom strontium ranelate (2 g) bħala granuli biex jitħalltu għal suspensjoni li għandha tittieħed mill-ħalq.
English: What is happening with Protelos/Osseor for the treatment of osteoporosis?
Maltese: Protelos/Osseor (strontium ranelate)
English: In osteoarthritis, the cartilage, a smooth layer that lines the joints and helps them to move easily, is gradually lost, and the bone underneath becomes damaged and exposed.
Maltese: F'osteoartrite, il-kartilaġni, saff lixx li jdawwar il-ġogi u jgħinhom jiċċaqalqu iktar faċilment, jintilef gradwalment, u l-għadam ta' taħt iġarrab ħsara u jiġi espost.
English: The company informed the CHMP that there are no consequences for any ongoing clinical trials with Protelos/Osseor.
Maltese: Il-kumpanija infurmat lis-CHMP li ma hemm ebda konsegwenza għal kwalunkwe prova klinika li għaddejja bi Protelos/Osseor.
English: What were the reasons given by the company for withdrawing the applications?
Maltese: X'kienu r-raġunijiet mogħtija mill-kumpanija għall-irtirar tal applikazzjonijiet?
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Protelos/Osseor could not have been approved for the treatment of osteoarthritis.
Maltese: Abbażi tar-reviżjoni tad-dejta u t-twġiba tal-kumpanija għal-listi ta' mistoqsijiet tas-CHMP, fiż-żmien tal-irtirar, is-CHMP kellu xi tħassib u kien tal-fehma provviżorja li Protelos/Osseor ma setax jiġi approvat għall-kura ta' osteoartrite.
English: Protelos/Osseor was also expected to be used to treat osteoarthritis (a long-term disease that damages joints and makes them stiff and painful) in the knee and hip.
Maltese: Protelos/Osseor kien mistenni li jintuża wkoll għall-kura ta' osteoartrite (marda fit-tul li tagħmel ħsara lill-ġogi u tagħmilhom ibsin u b'uġigħ) fl-irkoppa u fil-ġenbejn.
English: The CHMP noted that the size of the benefit seen in the study was small and the long-term benefit unclear, whereas the medicine had an established risk of serious side effects.
Maltese: Is-CHMP innota li l-ammont ta' benefiċċju li ntwera fl-istudju kien żgħir u l-benefiċċju fit-tul ma kienx ċar, filwaqt li l-mediċina kellha riskju stabbilit ta' effetti sekondarji serji.
English: What was Protelos/Osseor expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Protelos/Osseor?
English: After the CHMP had assessed the company's responses to the last round of questions, there were still some unresolved issues.
Maltese: Wara li s-CHMP kien evalwa t-tweġibiet tal-kumpanija salaħħar sessjoni ta' mistoqsijiet, xorta kien għad baqa' kwistjonijiet mhux solvuti.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Protelos/Osseor in the treatment of osteoarthritis did not outweigh its risks.
Maltese: Ir-Rapport Pubbliku Ewropew ta' Valutazzjoni komplut għal Protelos/Osseor jista' jinstab fuq is-sit elettroniku tal-Aġenzija:
English: Packaging name
Maltese: Daqs tal-pakkett
English: Invented Strength Pharmaceutical Form Route of Administration
Maltese: Għamla farmaċewtika