FrancophonIA/ELRC3.0 huggingface dataset:
English: This property could be beneficial when the use of vasoconstrictor is contraindicated.
Maltese: Din il-proprjetà tista' tkun ta' benefiċċju meta l-użu ta' vażokostrittur ikun kontraindikat.
English: Clinical studies were not performed in pregnant women and no cases of pregnant women injected with mepivacaine 30 mg/ml were reported in the literature.
Maltese: L-istudji kliniċi ma sarux fuq nisa' tqal u ma ġie rrappurtat l-ebda każ fil-letteratura ta' nisa tqal injettati b'30 mg/ml ta' mepivacaine.
English: The following table lists the maximum allowed doses in adults for the most commonly used anaesthetic techniques and the equivalent in number of cartridges:
Maltese: It-tabella li ġejja telenka d-dożi massimi permissibbli fl-adulti għat-tekniki anestetiċi l-aktar komuni u lekwivalenti fin-numru ta' kartriġis:
English: • Poorly controlled epileptic patient.
Maltese: • Disturbi severi tal-konduzzjoni atrijoventrikulari mhux ikkumpensati minn pacemaker, • Pazjent epilettiku kkontrollat ħażin.
English: Not known Nerve injury
Maltese: Korriment tan-nervituri
English: − failure of the heart to contract effectively (myocardial depression);
Maltese: − nuqqas li l-qalb tħabbat b'mod effettiv (depressjoni mijokardika);
English: Initial symptoms include agitation, a feeling of intoxication, a sensation of numbness in the lips and tongue, paraesthesia around the mouth, dizziness, visual and hearing disturbances, and buzzing in the ears.
Maltese: Sintomi inizjali jinkludu aġitazzjoni, sensazzjoni ta' intossikazzjoni, sensazzjoni ta' tnemnim fix-xufftejn u l-ilsien, parestesija madwar il-ħalq, sturdament, disturbi viżivi u tas-smigħ, u żanżin fil-widnejn.
English: OTHER
Maltese: Koma
English: Dizziness (including vertigo, vision disorder and fatigue) may occur following administration of mepivacaine (see section 4.8).
Maltese: Wara l-għoti tal-mepivacaine jista' jkun hemm sturdament (inkluż vertigo, disturbi fil-vista u għeja) (ara s-sezzjoni 4.8).
English: General disorders and administration site conditions
Maltese: Disturbi ġenerali u kundizzjonijiet tas-sit ta' amministrazzjoni
English: If signs of acute systemic toxicity appear, injection of the local anaesthetic should be stopped immediately.
Maltese: Jekk jidhru sinjali ta' tossiċità sistemika akuta, l-injezzjoni tal-anestetiku lokali għandha titwaqqaf immedjatament.
English: The following symptoms may be signs of toxicity due to excessive doses of local anaesthetics: agitation, a sensation of numbness in the lips and tongue, prickling and tingling around the mouth, dizziness, visual and hearing disturbances, and buzzing in the ears, muscle stiffness and twitching, low blood pressure, low or irregular heart rate.
Maltese: Is-sintomi li ġejjin jistgħu jkunu sinjali ta' tossiċità minħabba doża eċċessiva ta' anestetiċi lokali: aġitazzjoni, sensazzjoni ta' xufftejn u lsien reqdin, tingiż u tixwik madwar il-ħalq, sturdament, disturbi viżivi u tas-smigħ, u żanżin fil-widnejn; ebusija u ġbid fil-muskoli, pressjoni baxxa tad-demm, rata talqalb baxxa jew irregolari.
English: Not Known Euphoric mood Anxiety/Nervousness3
Maltese: Għeja, astenja (dgħjufija) Tħoss is-sħana
English: − increase of blood flow (hyperaemia);
Maltese: − żieda fil-fluss tad-demm (iperemija);
English: − swelling of the mouth, lips, tongue and gums, high saliva production;
Maltese: − nefħa tal-ħalq, xufftejn, ilsien u ħanek, produzzjoni ta' saliva għolja;
English: − pain due to nerve damage (neuropathic pain);
Maltese: - Għandek anemija severa;
English: Dizziness (including a feeling of “spinning”, vision disorder and fatigue), loss of consciousness may occur following administration of this medicine (see section 4).
Maltese: Sturdament (inkluż sensazzjoni ta' “tidwir”, disturbi fil-vista u għeja), jista' jseħħ telf ta' koxjenza wara lamministrazzjoni ta' din il-mediċina (ara s-sezzjoni 4).
English: Gingival / oral mucosal exfoliation (sloughing) / ulceration Swelling of tongue, lip, gums Not known Stomatitis, glossitis, gingivitis Salivary hypersecretion
Maltese: − raxx, ħakk, nefħa tal- wiċċ, ix-xufftejn, il-ħanek, l-ilsien u/jew il-gerżuma u diffikultà biex tieħu n nifs, tħarħir/ażma, ħorriqija (urtikarja):dawn jistgħu jkunu sintomi ta' reazzjonijiet ta' sensittività eċċessiva (reazzjonijiet allerġiċi jew bħal ta' allerġija);
English: Common side effects (may affect up to 1 in 10 people): Headache
Maltese: Komuni Effetti sekondarji (jista' jaffettwa sa 1 minn kull 10 persuni):
English: Single use type I glass cartridge, sealed at its base by a mobile type I synthetic rubber and at the top by a type I synthetic rubber seal kept in place by an aluminium cap.
Maltese: Kartriġ tal-ħġieġ tat-tip I ta' użu ta' darba, issiġillat fil-bażi tiegħu minn gomma sintetika tat-tip I mobbli u fil-parti ta' fuq permezz ta' siġill ta' gomma sintetika tat-tip I miżmum fil-post b'għatu tal-aluminju.
English: Cardiac disorders
Maltese: Disturbi kardijaċi
English: Very rare side effects (may affect up to 1 in 10,000 people): − high blood pressure.
Maltese: Rari ħafna effetti sekondarji (jista' jaffettwa sa 1 minn kull 1,000 persuna): − pressjoni tad-demm għolja.
English: Excipient(s) with known effect
Maltese: STQARRIJA TA' SUSTANZA(I) ATTIVA(I)
English: Infiltration and perineural use
Maltese: Infiltrazzjoni u użu madwar in-nerv
English: hypoesthesia, dysesthesia, hyperesthesia, etc) of the lips, tongue and oral tissues.
Maltese: ipoestesija, disestesija, iperestesija, eċċ.) tax-xufftejn, l-ilsien u t-tessuti orali.
English: The availability of appropriate resuscitation equipment and medication and adequately trained staff is recommended before induction of regional anaesthesia with local anaesthetics to enable prompt treatment of any respiratory and cardiovascular emergencies.
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Interazzjonijiet ta' addittivi ma' anestetiċi lokali oħra It-tossiċità tal-anestetiċi lokali hija addittiva.
English: Contains sodium, see package leaflet for further information.
Maltese: Mhux id-daqsijiet kollha tal-pakkett jistgħu jiġu kkummerċjalizzati.
English: − muscle twitching;
Maltese: − ġbid involontarju tal-muskoli;
English: 20 kg of body weight).
Maltese: iktar minn 4 snin (c.a. 20 kg ta' piż tal-ġisem).
English: Angina pectoris 6
Maltese: Uġigħ fis-sider
English: Sodium hydroxide (for pH-adjustment) Water for injection
Maltese: Idrossidu tas-sodju (għal aġġustament pH-)
English: Mepivacaine has a rapid onset, a high potency of anaesthesia and a low toxicity.
Maltese: Il mepivacaine għandu bidu mgħaġġel, saħħa għolja ta' anestesija u tossiċità baxxa.
English: Hyperhidrosis (sweating or perspiration)
Maltese: Iperidrożi (għaraq jew perspirazzjoni)
English: • Heart disorders due to the abnormality of the electronic impulse triggering the heart beat (severe conduction disturbances);
Maltese: • Mard tal-qalb minħabba l-anormalità tal-impuls elettroniku li jattiva għal taħbit tal-qalb (disturbi serji tal-konduzzjoni);
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 ml for solution for injection contains 30 mg of mepivacaine hydrochloride .
Maltese: 1 ml taħlita likwida għall-injezzjoni fiha 30 mg ta' kloridrat tal-mepivacaine.
English: Ear and labyrinth disorders
Maltese: Disturbi fil-widnejn u fissistema labirintika
English: If a rapid intravascular injection is administered, a high blood concentration of mepivacaine in the coronary arteries may lead to myocardial failure, possibly followed by cardiac arrest, before the CNS is affected.
Maltese: Jekk tintuża injezzjoni intravaskulari rapida, konċentrazzjoni għolja fid-demm tal-mepivacaine fl-arterji koronarji tista' twassal għal insuffiċjenza mijokardika, possibbilment segwita minn arrest kardijaku, qabel ma s-CNS tkun affettwata.
English: Patients who are being treated with antiarrhythmic drugs may encounter an accumulation of side effects after the use of mepivacaine due the similarity of structures (such as Class I drug i.e. lidocaine).
Maltese: Pazjenti li qed jiġu kkurati b'mediċini antiarritmiċi jista' jkollhom akkumulazzjoni ta' effetti kollaterali wara l-użu ta' mepivacaine minħabba x-xebħ tal-istrutturi (bħal mediċina tal-Klassi I jiġifieri lidocaine).
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
Maltese: Meta tirrapporta effetti sekondarji, tista' tgħin billi tipprovdi aktar informazzjoni dwar is-sigurtà ta' din il-mediċina.
English: The immediate availability of oxygen, other resuscitative drugs, cardiopulmonary resuscitative equipment, and the personnel resources needed for proper management of toxic reactions and related emergencies should be considered (see section 4.2).
Maltese: Għandhom jiġu kkunsidrati d-disponibbiltà immedjata ta' ossiġenu, ta' drogi ta' risuxxitazzjoni oħra, tagħmir ta' risuxxitazzjoni kardjopulmonari u r-riżorsi umani meħtieġa għal immaniġġjar tajjeb ta' reazzjonijiet tossiċi u emerġenzi relatati (ara s- sezzjoni 4.2).
English: Talk to your dentist before using X if: - You suffer from heart disorders; - You have a severe anaemia; - You suffer from high blood pressure (severe or untreated hypertension); - You suffer from a low blood pressure (hypotension); - You suffer from epilepsy; - You suffer from liver disease; - You suffer from kidney disease; - You suffer from a disease which affects the nervous system and results in neurological disorders
Maltese: Din id-dejta oriġinat f'rapporti ta' wara t-tqegħid fis-suq, l-aktar wara bblokkar tan-nervituri fil-mandibola (xedaq), li jinvolvu diversi fergħat tan-nerv triġeminali; 5 l-aktar f'pazjenti b'mard kardijaku sottostanti jew lil dawk li jirċievu ċerti mediċini;
English: Do not use X: - If you are allergic to mepivacaine or any of the other ingredients of this medicine (listed in section 6); - if you are allergic to other local anaesthetics of the same group (e.g. lidocaine, bupivacaine); - If you suffer from:
Maltese: - jekk int allerġiku għal anestetiċi lokali oħra tal-istess grupp (eż. lidocaine, bupivacaine);
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Maltese: Ir-rapportar ta' reazzjonijiet avversi ssuspettati wara l-awtorizzazzjoni tal-prodott mediċinali huwa importanti.
English: − failure of the heart to contract effectively (cardiac arrest), rapid and erratic heartbeats (ventricular fibrillation), severe and crushing chest pain (angina pectoris);
Maltese: − insuffiċjenza tal-qalb biex tħabbat sew (arrest kardijaku), taħbit tal-qalb mgħaġġel u erratiku (fibrillazzjoni ventrikulari), uġigħ serju u tat-tgħaffiġ tas-sider (anġina pectoris);
English: Confusional state, disorientation Speech disorder3 (e.g., dysarthria, logorrhea)
Maltese: Stat konfużjonali, diżorjentament Disturbi fid-diskors3 (eż., disartrija,
English: Pruritus
Maltese: Mhux
English: Package leaflet: Information for the patient {Scandonest and associated names (see Annex I) strength pharmaceutical form} [See Annex I - To be completed nationally]
Maltese: Informazzjoni għall-pazjent {Scandonest u l-ismijiet assoċjati (ara l-Anness I) saħħa tal-forma farmaċewtika} [Ara l-Anness I - Għandu jimtela nazzjonalment]
English: − metallic taste, taste distortion, taste loss (dysesthesia);
Maltese: − togħma metallika, distorsjoni tat-togħma, telf ta' togħma (disestesija);
English: CYP1A2 inhibitors
Maltese: /larinġi1 / edema periorbitali)
English: Cimetidine reduces the clearance of mepivacaine.
Maltese: Id-dijalisi mhijiex effettiva fit-trattament ta' doża eċċessiva ta' Mepivacaine.
English: The medicinal product should only be used by or under the supervision of dentists, stomatologists or other clinicians sufficiently trained and familiar with diagnosis and treatment of systemic toxicity.
Maltese: Il-prodott mediċinali għandu jintuża minn jew taħt is-superviżjoni ta' dentisti, stomatologi jew kliniċisti oħra u mħarrġa biżżejjed fid-dijanjożi u fit-trattament ta' tossiċità sistemika.
English: What X looks like and contents of the pack
Maltese: Id-dehra ta' X u l-kontenuti tal-pakkett
English: The ratio of the average plasma levels following one and two cartridges were approximately 50%, evidencing a dose proportionality at these dose levels.
Maltese: Il-proporzjon tal-livelli tal-plażma li ġejjin kien ta' madwar 50%, li juri proporzjonalità fid-doża f'dawn il-livelli tad-doża.
English: Mepivacaine is metabolized by the liver and can lead to elevated plasma levels in patients with hepatic impairment, in particular after repeated use.
Maltese: Il-mepivacaine huwa metabolizzat mill-fwied u jista' jwassal għal livelli għoljin ta' plażma f'pazjenti b'indeboliment epatiku, b'mod partikolari wara użu ripetut.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI
English: Risk of biting trauma (lips, cheeks, mucosa, and tongue) exists, especially in children; the patient should be told to avoid chewing gum or eating until normal sensation is restored.
Maltese: Jeżisti riskju ta' trawma tal-gdim (ix-xufftejn, il-ħaddejn, il-mukuża u l-ilsien), speċjalment fit-tfal; ilpazjent għandu jiġi mgħarraf biex jevita ċ-chewing gum jew l-ikel sakemm terġa' lura s-sensazzjoni normali.
English: Ref. EMEA/CHMP/319054/2008
Maltese: EMEA/CHMP/319054/2008
English: London, 26 June 2008 Doc.
Maltese: Londra, 26 ta' unju 2008 Dok. Ref.
English: 1 Article 31 of Directive 2001/83/EC as amended, referral under Community interest.
Maltese: Artikolu 31 tad-Direttiva 2001/83/KE kif emendata, referenza fl-interess Komunitarju.
English: • a reduction of the maximum recommended dose to 3 mg per day;
Maltese: • tnaqqis tad-do a massima rakkomandata g al 3 mg kuljum;
English: The dose of bromocriptine should also be limited to 30 mg a day.
Maltese: Id-do a ta' bromocriptine g andha ti i limitata g al 30 mg kuljum ukoll.
English: • To reduce the risk of cardiac fibrosis, patients should be prescribed a daily maximum of 3 mg pergolide or cabergoline, or 30 mg bromocriptine.
Maltese: • Sabiex jitnaqqas ir-riskju ta' fibro i tal-qalb, il-pazjenti g andhom jing ataw do a massima ta' 3 mg pergolide jew cabergoline, jew 30 mg bromocriptine kuljum.
English: Ergot-derived dopamine agonists are a group of medicines consisting of bromocriptine, cabergoline, dihydroergocryptine, lisuride and pergolide.
Maltese: L-agonisti tad-dopamina derivati mill-ergot huma grupp ta' medi ini li huma mag mulin minn bromocriptine, cabergoline, dihydroergocryptine, lisuride u pergolide.
English: This review was carried out under an ‘Article 31' referral1.
Maltese: Din ir-revi joni saret b'referenza tal-‘Artikolu 31'
English: • a warning stating that patients must be monitored for signs of fibrosis with echocardiography before treatment is started and regularly during treatment;
Maltese: • avvi li jiddikjara li l-pazjenti g andhom ji u mmonitorjati g al sinjali ta' fibro i bl ekokardjografija qabel ma jinbeda t-trattament u b'mod regolari waqt it-trattament;
English: They are also used to treat conditions including hyperprolactinaemia (high levels of the hormone prolactin in the blood) and prolactinoma (a non-cancerous tumour of the pituitary gland at the base of the brain), and to prevent lactation (production of breast milk) and migraine.
Maltese: Jintu aw ukoll g all-kura ta' kundizzjonijiet inklu i l-iperprolaktinemija (livelli g oljin tal-ormon prolaktin fid-demm) u prolaktinoma (tumur mhux kan eru tal-glandola pitwarja fin-na a t'isfel tal-mo ), u g all-prevenzjoni tal-lattazzjoni (il-produzzjoni tal- alib mis-sider) u talemigranji.
English: Dopamine agonists work by stimulating brain and nerve cells in a similar way to dopamine, a messenger substance in the nervous system.
Maltese: L-agonisti tad-dopamina ja dmu billi jistimolaw i - elluli tal-mo u tan-nervituri b'mod simili g al kif tag mel id-dopamina, sustanza messa iera fis-sistema nervu a.
English: This group of dopamine agonists are called ‘ergotderived', because they were first produced from a type of fungus called ergot.
Maltese: Dan il-grupp ta' agonisti taddopamina jissej u ‘derivati mill-ergot', g aliex ew prodotti l-ewwel darba minn tip ta' fungus imsejja ergot.
English: • ‘cardiac fibrosis' as a ‘very common' side effect (seen in more than 1 patient in 10 taking either medicine).
Maltese: • ‘il-fibro i tal-qalb' b ala effett sekondarju ‘komuni afna' (osservat f'aktar minn pazjent wie ed f'kull 10 pazjenti li qeg din jie du wa da minn dawn il-medi ini).
English: What are ergot-derived dopamine agonists?
Maltese: X'inhuma l-agonisti tad-dopamina derivati mill-ergot?
English: The review focused on the risk of fibrosis (the formation of fibrous tissue in some body structures) in patients taking these medicines for long periods, particularly cardiac fibrosis (abnormal thickening of the heart valves).
Maltese: Ir-revi joni ffukat fuq ir-riskju ta' fibro i (il-formazzjoni ta' tessut fibru f'xi strutturi tal isem) f'pazjenti li jie du dawn il-medi ini g al perijodi twal, b'mod partikolari l-fibro i tal-qalb (itt axxin mhux normali tal-valvi tal-qalb).
English: • Patients should be monitored for the signs of fibrosis in the heart and elsewhere in the body throughout treatment, using blood tests or chest X-rays as appropriate.
Maltese: • Il-pazjenti g andhom ji u mmonitorjati g al sinjali ta' fibro i fil-qalb u f'postijiet o ra talisem waqt it-trattament kollu, permezz ta' testijiet tad-demm jew X-rays tas-sider kif xieraq.
English: All five medicines are authorised by regulatory authorities in Member States.
Maltese: Il- ames medi ini kollha huma awtorizzati minn awtoritajiet regolatorji fl-Istati Membri.
English: For cabergoline and pergolide, the Committee noted that the risk of fibrosis of the heart valves is well established, that the prescribing information for both products already includes contraindications stating that patients with evidence of heart valve problems should not take them, and that the medicines should only be used for Parkinson's disease in patients who have already taken or cannot take other treatments.
Maltese: G al cabergoline u pergolide, il-Kumitat osserva li r-riskju ta' fibro i tal-valvi tal-qalb huwa stabbilit sew, li l-informazzjoni ta' kif g andhom jittie du - ew prodotti di à tinkludi kontraindikazzjonijiet li jiddikjaraw li l-pazjenti b'evidenza ta' problemi fil-valvi tal-qalb m'g andhomx jie duhom, u li lmedi ini g andhom jintu aw biss g all-marda tal-Parkinson g all-pazjenti li di à adu jew li ma jistg ux jie du trattamenti o ra.
English: The European Medicines Agency (EMEA) has completed a review of the safety of the ergot-derived dopamine agonists, a group of medicines that are mainly used to treat Parkinson's disease.
Maltese: L-A enzija Ewropea g all-Medi ini (EMEA) wettqet revi joni tas-sigurtà tal-agonisti tad-dopamina derivati mill-ergot, grupp ta' medi ini li jintu aw b'mod ewlieni g at-trattament tal-marda talParkinson.
English: Based on the information available, the CHMP has concluded that the marketing authorisations for the ergot-derived dopamine agonists should be maintained, but changes to the prescribing information for the medicines should be introduced to reduce the risk of fibrosis.
Maltese: Madankollu, g andhom ji u introdotti restrizzjonijiet fuq il-mod kif jintu aw dawn il-medi ini, sabiex jitnaqqas irriskju li ti viluppa l-fibro i.
English: QUESTIONS AND ANSWERS ON THE REVIEW OF ERGOT-DERIVED DOPAMINE AGONISTS
Maltese: TADDOPAMINA DERIVATI
English: Among the ergot-derived dopamine agonists, cabergoline and pergolide activate these receptors most strongly, possibly explaining the greater risk of fibrosis seen with these medicines.
Maltese: Fost l-agonisti tad-dopamina derivati mill-ergot, cabergoline u pergolide jattivaw lil dawn ir-ri etturi b'mod l-aktar qawwi, li jista' jispjega r-riskju akbar ta' fibro i osservat b'dawn il-medi ini.
English: Why have ergot-derived dopamine agonists been reviewed?
Maltese: G aliex ew riveduti l-agonisti tad-dopamina derivati mill-ergot?
English: In addition, the CHMP recommended that a contraindication for patients with pre-existing valve problems should be included in the prescribing information for bromocriptine and dihydroergocryptine-containing medicines.
Maltese: Barra minn hekk, is-CHMP irrakkomanda li ti i inklu a kontraindikazzjoni g all-pazjenti li di à g andhom problemi tal-valvi fl-informazzjoni tar-ri etti g all-medi ini li fihom bromocriptine u dihydroergocryptine.
English: However, since such a risk cannot completely be excluded, the Committee recommended that warnings on the possible risk of fibrosis in patients taking these medicines at high doses for long periods should be included in their prescribing information.
Maltese: Madankollu, min abba li tali riskju ma jistax ji i esklu g al kollox, il-Kumitat irrakkomanda li t-twissijiet dwar ir-riskju possibbli ta' fibro i f'pazjenti li jkunu qeg din jie du dawn il-medi ini f'do i g oljin g al perijodi twal g andhom ikunu nklu i fl-informazzjoni tar-ri etta tag hom.
English: Consequently, the United Kingdom's medicines regulatory authority asked the CHMP to review the risk of fibrosis, including cardiac fibrosis, associated with the use of ergot-derived dopamine agonists.
Maltese: G alhekk, l-awtorità regolatorja tal-medi ini tar-Renju Unit talbet lis-CHMP biex jirrevedi r-riskju tal-fibro i, inklu a l-fibro i tal-qalb, asso jat mal-u u ta' agonisti tad-dopamina derivati mill-ergot.
English: The CHMP reviewed all of the available information on the risk of fibrosis and valve problems from clinical trials, observational studies (studies looking at the effects of medicines as they are used by patients) and ‘spontaneous reports' of side effects made by patients or doctors to the companies that make the medicines or to health authorities.
Maltese: Is-CHMP irreveda l-informazzjoni kollha disponibbli dwar ir-riskju ta' fibro i u l-problemi tal-valvi minn provi klinii, studji ta' osservazzjoni (studji li jeaminaw l-effetti tal-mediini waqt li jkunu
English: The absence of fibrosis in the heart should be verified before treatment is started.
Maltese: In-nuqqas ta' fibro i fil-qalb g andha ti i vverifikata qabel ma jinbeda t-trattament.
English: • Ergot-derived dopamine agonists should not be taken by patients who have had fibrosis in the heart, lungs or abdomen.
Maltese: • L-agonisti tad-dopamina derivati mill-ergot m'g andhomx jittie du minn pazjenti li kellhom fibro i fil-qalb, fil-pulmuni jew fl-addome.
English: --1 ≥ 394AU/ml (Antigenic units determined by ELISA) (1400 AU corresponding to ≥ 492 AU in the potency test)
Maltese: --1 ≥ 394AU/ml (Units antiġeniċi determinati b' ELISA) (1400 AU jikkorrispondu għall ≥ 492 AU fit-test tal-qawwa)
English: Packaging Content Package size
Maltese: Kontenut Daqs tal-pakett
English: Route of administration
Maltese: Metodu ta' amministrazzj oni
English: Vial (type I glass) closed with a rubber stopper secured with aluminium cap
Maltese: Fil-muskolu Kunjett (ħġieġ tip I) magħluq b'tapp tal-gomma assigurat b'kappa tal-aluminju
English: 10 vials Zero days
Maltese: 10 kunjetti Xejn ġranet
English: EU Number
Maltese: Ippakjar
English: 14 December 2012 EMA/807998/2012 EMEA/H/C/2259
Maltese: EMA/20337/2013EMA/771962/2012 EMEA/H/C/2259
English: It was to be available as 10 mg tablets.
Maltese: Kien se jkun disponibbli bħala pilloli ta' 10 mg.
English: What is Jenzyl?
Maltese: X'inhu Jenzyl?
English: Jenzyl is a medicine that contains the active substance ridaforolimus.
Maltese: Jenzyl huwa mediċina li fiha s-sustanza attiva ridaforolimus.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Jenzyl can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation (soft tissue sarcoma and primary malignant bone tumours).
Maltese: ema.europa.eu/Find medicine/Human medicines/Rare disease designation (soft tissue sarcoma u primary malignant bone tumours).
English: The study compared Jenzyl with placebo (a dummy treatment).
Maltese: L-istudju qabbel Jenzyl ma' plaċebo (trattament finta).