FrancophonIA/ELRC3.0 huggingface dataset:
English: When trastuzumab was administered after completion of adjuvant chemotherapy NYHA class III-IV heart failure was observed in 0.6% of patients in the one-year arm after a median follow-up of 12 months.
Maltese: Meta trastuzumab ingħata wara t-tmiem ta' kimoterapija awżiljarja, kienet osservata insuffiċjenza talqalb ta' NYHA klassi III-IV f'0.6% tal-pazjenti fil-grupp ta' sena wara segwitu medjan ta' 12-il xahar.
English: Amgen Biotechnologia Sp. z o.o.
Maltese: Informazzjoni għall-utent
English: Biopsy specimen - staining pattern HER2 overexpression assessment
Maltese: Valutazzjoni tal-espressjoni żejda ta' HER2
English: EXP
Maltese: MBC
English: The data suggest that beneficial effects were greater among those patients with higher levels of overexpression of HER2 (3+).
Maltese: Id-data tindika li effetti tajbin kienu akbar fost dawk ilpazjenti b'livelli ogħla ta' espressjoni żejda ta' HER2 (3+).
English: Regimen Primary tumour type
Maltese: KLASSIFIKAZZJONI ĠENERALI
English: • high potassium levels
Maltese: GĦAMLA KWALITATTIVA
English: • cisplatin - 80 mg/m2 every 3 weeks for 6 cycles on day 1 of each cycle.
Maltese: It-tnejn ingħataw ma': - cisplatin - 80 mg/m2 kull 3 ġimgħat għal 6 ċikli fl-ewwel ġurnata ta' kull ċiklu.
English: EBC is defined as non-metastatic primary invasive carcinoma of the breast.
Maltese: EBC huwa definit bħala karċinoma primarja, invasiva, mhix metastatika tas-sider.
English: After reconstitution 1 mL concentrate contains 21 mg of trastuzumab.
Maltese: Wara r-rikostituzzjoni 1 mL ta' konċentrat ikun fih 21 mg ta' trastuzumab.
English: Cystitis
Maltese: Metastasi
English: Hazard Ratio (95% CI)
Maltese: Proporzjon ta' Periklu (CI ta' 95%)
English: In all patients cardiac function should be monitored during treatment (e.g. every 12 weeks).
Maltese: Il-funzjoni kardijaka għandha tiġi mmonitorjata waqt it-trattament (eż. kull 12-il ġimgħa) fil-pazjenti kollha.
English: AC→DH (n = 1074) Hazard Ratio vs AC→D (95% CI) p-value
Maltese: Proporzjon ta' Periklu kontra AC→D (CI ta' 95%) valur p
English: KANJINTI and anthracyclines should not be given concurrently in combination in the adjuvant treatment setting.
Maltese: KANJINTI u anthracyclines m'għandhomx jingħataw fl-istess waqt flimkien f'sitwazzjoni ta' trattament awżiljarju.
English: 4 cycles.
Maltese: Tabella 4.
English: There was no evidence of acute or multiple dose-related toxicity in studies of up to 6 months, or reproductive toxicity in teratology, female fertility or late gestational toxicity/placental transfer studies.
Maltese: Ma kien hemm l-ebda evidenza ta' effett tossiku akut jew relatat ma' dożi multipli fi studji li damu sa 6 xhur, jew fi studji dwar l-effett tossiku fuq is-sistema riproduttiva fit-teratoloġija, fertilità femminili jew effett tossiku fl-aħħar tal-ġestazzjoni/trasferiment mill-plaċenta. trastuzumab mhux ġenotossiku.
English: or - intravenous docetaxel - 75 mg/m2 as an intravenous infusion over 1 hour, given every 3 weeks for 6 cycles (day 2 of cycle 1, then day 1 of each subsequent cycle) which was followed by: - carboplatin - at target AUC = 6 mg/mL/min administered by intravenous infusion over
Maltese: jew - 5-fluorouracil fil-vini - 800 mg/m2/jum bħala infużjoni kontinwa fil-vini fuq 5 ijiem, mogħtija kull 3 ġimgħat għal 6 ċikli (ġranet 1 sa 5 ta' kull ċiklu)
English: The median duration of follow-up was 1.8 years for the patients in the AC→P arm and 2.0 years for patients in the AC→PH arm. Table 7 Summary of efficacy results from the joint analysis of the NSABP B-31 and NCCTG N9831 trials at the time of the definitive DFS analysis*
Maltese: Sommarju ta' riżultati tal-effikaċja mill-analiżi konġunta tal-provi NSABP B-31 u NCCTG N9831 fil-ħin tal-analiżi definittiva ta' DFS*
English: • redness, swelling or sores in your mouth and/or throat
Maltese: • uġigħ, nefħa, ħmura jew tnemnim tal-idejn u/jew saqajn
English: Median Survival (months) (95%CI)
Maltese: Sopravivenza medjana (xhur) (CI ta' 95%)
English: Effect of trastuzumab on the pharmacokinetics of other antineoplastic agents
Maltese: Effett ta' trastuzumab fuq il-farmakokinetika ta' sustanzi antineoplastiċi oħra
English: Cellulitis
Maltese: Artralġja
English: KANJINTI should only be used in patients with metastatic or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay (see sections 4.4 and 5.1).
Maltese: Huwa meħtieġ ittestjar għal HER2 qabel tinbeda t-terapija (ara sezzjonijiet 4.4 u 5.1).
English: • runny nose
Maltese: Reazzjoni avversa
English: Combination treatment with trastuzumab and anastrozole Trastuzumab has been studied in combination with anastrozole for first line treatment of MBC in HER2 overexpressing, hormone-receptor (i.e. oestrogen-receptor (ER) and/or progesterone-receptor (PR)) positive postmenopausal patients.
Maltese: Trattament kombinata b'trastuzumab u anastrozole trastuzumab kien studjat f'kombinazzjoni ma' anastrozole għat-trattament ippreferut ta' MBC f'pazjenti wara l-menopawża li kienu posittivi għall-espressjoni żejda ta' HER2, għar-riċettur talormon (jiġifieri riċettur ta' estrogen (ER - oestrogen-receptor) u/jew riċettur ta' progesterone (PRprogesterone-receptor)).
English: • chest pain
Maltese: • fsada mill-imnieħer
English: Deafness
Maltese: Rimettar
English: The extracellular domain of the receptor (ECD, p105) can be shed into the blood stream and measured in serum samples.
Maltese: Id-dominju ekstraċellulari tarriċettur (ECD, p105 - extracellular domain, p105) jista' jmur fid-demm u jitkejjel f'kampjuni tasserum.
English: • abnormal or impaired blood clotting
Maltese: • diffikultà biex tieħu nifs meta mindud
English: The pre-planned final analysis of OS from the joint analysis of studies NSABP B-31 and NCCTG N9831 was performed when 707 deaths had occurred (median follow-up 8.3 years in the AC→PH group).
Maltese: L-analiżi finali ppjanata minn qabel ta' OS mill-analiżi konġunta tal-istudji NSABP B-31 u NCCTG N9831 kienet imwettqa meta seħħew 707 imwiet (segwitu medjan ta' 8.3 snin fil-grupp ta' AC→PH).
English: In patients who receive anthracycline-containing chemotherapy further monitoring is recommended, and should occur yearly up to 5 years from the last administration of KANJINTI, or longer if a continuous decrease of LVEF is observed.
Maltese: F'pazjenti li jirċievu kimoterapija li fiha anthracycline huwa rakkomandat aktar monitoraġġ, u dan għandu jseħħ kull sena sa 5 snin wara l-aħħar għoti ta' KANJINTI, jew aktar jekk jiġi osservat tnaqqis kontinwu ta' LVEF.
English: 1Muscle tightness
Maltese: Jekk tirċievi
English: Most patients who developed CHF or asymptomatic cardiac dysfunction in pivotal trials improved with standard CHF treatment consisting of an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) and a beta-blocker.
Maltese: Jekk tiżviluppa insuffiċjenza sintomatika tal-qalb waqt terapija b'KANJINTI, għandha tiġi ttrattata bi prodotti mediċinali standard għal CHF. Il-biċċa l-kbira tal-pazjenti li żviluppaw CHF jew disfunzjoni kardijaka bla sintomi fil-provi pivitali marru għall-aħjar b'kura standard għal CHF li tikkonsisti minn inibitur tal-enzima li tittrasforma lill-angiotensin (ACE - angiotensin-converting enzyme) jew imblokkatur tar-riċettur ta' angiotensin (ARB - angiotensin receptor blocker) u imblokkatur tarriċetturi beta.
English: The efficacy results from the BO16348 trial following 12 months* and 8 years** median follow-up are summarised in table 6:
Maltese: Ir-riżultati tal-effikaċja mill-prova BO16348 wara segwitu medjan ta' 12-il xahar* u ta' 8 snin** huma miġbura fil-qosor f'tabella 6:
English: Regimen Primary tumour type N
Maltese: Programm ta' kull 3 ġimgħat
English: White to pale yellow lyophilised powder.
Maltese: Kull kartuna fiha kunjett wieħed.
English: Trastuzumab may persist in the circulation for up to 7 months after stopping KANJINTI treatment based on population pharmacokinetic analysis of all available data (see section 5.2).
Maltese: Ibbażat fuq analiżi tal-farmakokinetika tal-popolazzjoni tad-data kollha disponibbli trastuzumab jista' jippersisti fiċ-ċirkolazzjoni sa 7 xhur wara l-waqfien tat-trattament b'KANJINTI (ara sezzjoni 5.2).
English: Paresis
Maltese: Ansjetà
English: Progression free survival was doubled in the trastuzumab plus anastrozole arm compared to anastrozole (4.8 months versus 2.4 months).
Maltese: Is-sopravivenza mingħajr progressjoni irduppjat fil-grupp ta' trastuzumab flimkien ma' anastrozole meta mqabbel ma' anastrozole (4.8 xhur kontra 2.4 xhur).
English: Subsequent KANJINTI maintenance doses (weekly regimen: 2 mg/kg; three-weekly regimen 6 mg/kg respectively) should be administered 7 days or 21 days later according to the weekly or three-weekly schedules respectively.
Maltese: 6 mg/kg, rispettivament) għandhom jingħataw 7 ijiem jew 21 jum wara skont il-programmi ta' darba fil-ġimgħa jew ta' darba kull tliet ġimgħat, rispettivament.
English: Congestive heart failure (NYHA class II - IV) is a common adverse reaction associated with the use of trastuzumab and has been associated with a fatal outcome (see section 4.4).
Maltese: Insuffiċjenza konġestiva tal-qalb (NYHA klassi II - IV) hija reazzjoni avversa komuni assoċjata malużu ta' trastuzumab u kienet assoċjata ma' riżultat fatali (ara sezzjoni 4.4).
English: Somnolence
Maltese: Infezzjoni
English: Table 4 Efficacy results from the monotherapy and combination therapy studies
Maltese: Riżultati tal-effikaċja mill-istudji ta' monoterapija u ta' terapija kombinata
English: In the joint analysis of the NSABP B-31 and NCCTG N9831 studies, EBC was limited to women with operable breast cancer at high risk, defined as HER2-positive and axillary lymph node positive or
Maltese: Fl-analiżi konġunta tal-istudji NSABP B-31 u NCCTG N9831, EBC kien limitat għal nisa b'kanċer operabbli tas-sider li kellhom riskju għoli, definit bħala pożittiv għal HER2 u pożittiv għall-glandoli limfatiċi ta' taħt l-abt jew pożittiv għal HER2 u negattiv għall-glandoli limfatiċi ta' taħt l-abt b'fatturi ta' riskju għoli (daqs tat-tumur ta' > 1 ċm u negattiv għal ER jew daqs tat-tumur ta' > 2 ċm, irrispettivament mill-istat tal-ormoni).
English: After a median follow-up of 12 months, the hazard ratio (HR) for disease-free survival (DFS) was 0.54 (95% CI 0.44, 0.67) which translates into an absolute benefit, in terms of a 2-year disease-free survival rate, of 7.6 percentage points (85.8% versus 78.2%) in favour of the trastuzumab arm.
Maltese: Wara segwitu medjan ta' 12-il xahar, il-proporzjon ta' periklu (HR - hazard ratio) għas-sopravivenza mingħajr ilmarda (DFS - disease free survival) kien ta' 0.54 (CI ta' 95% 0.44, 0.67) li huwa definit bħala benefiċċju assolut, f'termini ta' rata ta' sopravivenza mingħajr il-marda ta' sentejn, ta' 7.6 punti perċentwali (85.
English: Erysipelas
Maltese: Ortopnija
English: Patients experiencing dyspnoea at rest due to complications of advanced malignancy and comorbidities may be at increased risk of pulmonary events.
Maltese: Pazjenti li jkollhom qtugħ ta' nifs waqt li mistrieħa minħabba komplikazzjonijiet ta' tumur malinn avvanzat u ta' mard ieħor fl-istess waqt jistgħu jkunu f'riskju akbar ta' avvenimenti pulmonari.
English: • bumpy rash
Maltese: Dożi maqbuża
English: Abdominal pain
Maltese: Newtropenija bid-deni
English: Nivolumab - Pemphigoid (EPITT no 18759)
Maltese: Nivolumab - Pemphigoid (EPITT nru 18759)
English: Undesirable effects e Rash is a composite term which includes maculopapular rash, rash erythematous, rash pruritic, rash follicular, rash macular, rash morbilliform, rash papular, rash pustular, rash papulosquamous, rash vesicular, rash generalised, dermatitis, dermatitis acneiform, dermatitis allergic, dermatitis atopic, dermatitis bullous, dermatitis exfoliative, dermatitis psoriasiform, and drug eruption and pemphigoid.
Maltese: .8. Effetti mhux mixtieqa e Raxx hu terminu kompost li jinkludi raxx makulopapulari, raxx ertematuż, raxx pruritiku, raxx follikulari, raxx makulari, raxx morbilliformi, raxx papulari, raxx pustulari, raxx papuloskwamuż, raxx vexxikulari, raxx ġeneralizzat, dermatite, dermatite akneiforme, dermatite allerġika, dermatite atopika, dermatite bulluża, dermatite esfoljattiva, dermatite psorjasiforme, u eruzzjoni tal-mediċina u pemfigojde.
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Maltese: Studji f'annimali wrew tossiċità riproduttiva (ara sezzjoni 5.3).
English: There have been reports of multiple congenital abnormalities (including brachycephalia, ears dysplasia, giant anterior fontanelle, femoral bowing and radio-humeral synostosis) in infants whose mothers were treated for at least three or more months with high doses (400-800 mg daily) of fluconazole for coccidioidomycosis.
Maltese: Kien hemm rapporti ta' diversi anormalitajiet konġenitali (inklużi brakiċefaleja, displasija talwidnejn, fontanelle anterjuri ġganti, tgħawwiġ femorali u sinostożi radjo-umerali) fi trabi li l-ommijiet tagħhom kienu ġew ikkurati għal mill-inqas tliet xhur jew iktar b'dożi għoljin (400-800 mg kuljum) ta' fluconazole għal koċċidijoidomikożi.
English: Pregnancy
Maltese: Tqala
English: An observational study has suggested an increased risk of spontaneous abortion in women treated with fluconazole during the first trimester.
Maltese: Studju ta' osservazzjoni ssuġġerixxa riskju akbar ta' abort spontanju f'nisa kkurati bi fluconazole matul l-ewwel trimestru.
English: Fluconazole - Spontaneous abortion and stillbirth (EPITT no 18666)
Maltese: 1. Fluconazole - Abort spontanju u twelid mejjet (EPITT nru
English: Adopted at the 6-9 February 2017 PRAC
Maltese: Adottati fil-PRAC ta' bejn is-6 u d-9 ta' Frar 2017
English: Data from several hundred pregnant women treated with standard doses (<200 mg/day) of fluconazole, administered as a single or repeated dose in the first trimester, show no increased risk of undesirable effects in the foetus.
Maltese: Data minn bosta mijiet ta' nisa tqal ikkurati b'dożi standard (<200mg/kuljum) ta' fluconazole, amministrat bħala doża waħda jew ripetuta fl-ewwel trimestru, ma urietx riskju akbar ta' effetti mhux mixtieqa fil-fetu.
English: 4 - Possible side effects Skin rash sometimes with blisters, itching
Maltese: Fuljett ta' tagħrif 4 - Effetti sekondarji possibbli Raxx tal-ġilda xi drabi b'infafet, ħakk
English: The elimination half-life (t1⁄2) is 40-50 minutes.
Maltese: Il-half life ta' eliminazzjoni (t1⁄2) hija ta' 40-50 minuta.
English: Lot.
Maltese: Lott.
English: Dogs: IM, IV Cats: IM
Maltese: Klieb: IM, IV Qtates:
English: 4.10 Overdose (symptoms, emergency procedures, antidotes)
Maltese: Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti)
English: Vomiting may occur 5-10 minutes after injection.
Maltese: Jista' jkun hemm remettar 5-10 minuti wara l-injezzjoni.
English: <{MM/YYYY}>
Maltese: <{XX/SSSS}>
English: Excipient(s):
Maltese: Ingredjent(i):
English: In the circulation, dexmedetomidine is largely bound to plasma proteins (>90%).
Maltese: Dexmedetomidine jabbina ħafna mal-proteini tal-plażma fiċ-ċirkolazzjoni (>90%).
English: Metabolites are excreted mainly in the urine (51% of the dose), and to a lesser extent in the faeces.
Maltese: Il-metaboliti jiġu eliminati l-aktar fl-urina (51% tad-doża) u xi ftit anqas fl-ippurgar.
English: Sodium hydroxide (E 524) (for pH adjustment) Hydrochloric acid (E507) (for pH adjustment) Water for injections
Maltese: Sodium hydroxide (E 524) (għall-aġġustament tal-pH) Hydrochloride acid (E507) (għall-aġġustament tal-pH)
English: A slight decrease in temperature may be observed.
Maltese: Jista' jkun hemm tnaqqis żgħir fit-temperatura.
English: In a clinical study, the requirement for propofol and thiopental was reduced by 30% and 60% respectively.
Maltese: Fi studju kliniku, il-bżonn ta' propofol u thiopental tnaqqas b'30% u 60% rispettivament.
English: Sedation lasts for at least 120 minutes post administration and analgesia lasts for at least 90 minutes.
Maltese: L-irqad idum mill-anqas 120 minuta wara l amministrazzjoni u s-serħan mill-uġiġħ idum mill-anqas 90 minuta.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT
Maltese: TA' PRODOTTI MEDIĊINALI
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: - 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 minn10 annimali f'1,000 annimal) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal, inklużi rapporti iżolati).
English: CP Pharma Handelsgesellschaft mbH Ostlandring 13, 31303 Burgdorf Germany
Maltese: CP Pharma Handelsgesellschaft mbH Ostlandring 13, 31303 Burgdorf
English: Ventricular arrhythmias have also been reported.
Maltese: Ġiet irrapportata wkoll arrhythmias ventrikolari.
English: Dexmedetomidine 500 micrograms/m2*
Maltese: Dexmedetomidine 500 mikrogrammi/m2*
English: The apparent volume of distribution (Vd) is 2.2 l/kg and the elimination half-life (t1⁄2) is one hour.
Maltese: Il volum ta' distribuzzjoni (Vd) jidher li huwa ta' 2.2 l/kg u l-half life ta' eliminazzjoni (t1⁄2) hija ta'
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: Dexmedetomidine 375 micrograms/m2
Maltese: Dexmedetomidine 375 mikrogrammi/m2
English: The bioavailability of dexmedetomidine is 60% and the apparent volume of distribution (Vd) is 0.9 l/kg.
Maltese: Il-bijodisponibilità fil-ġisem ta' dexmedetomidine hija ta' 60% u l-volum ta' distribuzzjoni (Vd) jidher li huwa ta' 0.9 l/kg.
English: Dexmedetomidine 125 micrograms/m2
Maltese: Dexmedetomidine 125 mikrogrammi/m2
English: The veterinary medicinal product is not intended for repeat injections.
Maltese: Il-prodott veterinarju mediċinali mhuwiex maħsub għal injezzjonijiet ripetuti.
English: (equivalent to dexmedetomidine
Maltese: (ekwivalenti għal dexmedetomidine
English: For the full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa tal-ingredjenti, ara s-sezzjoni 6.1.
English: Sedation may be reversed with atipamezole (see section 4.10).
Maltese: L-irqad jista' jiġi rriversjat b'atipamezole (ara sezzjoni 4.10).
English: The mean half-life of elimination of dexmedetomidine increased to 1.6 h and the total exposure (AUC) increased by 50%.
Maltese: Il-medja tal-half life ta' eliminazzjoni ta' dexmedetomidine żdiedet għal 1.6 sigħat u l-ammont totali (AUC) żdied b'50%.
English: When dexmedetomidine and butorphanol are used concomitantly in dogs, bradypnoea, tachypnoea, an irregular respiratory pattern (20-30 sec apnoea followed by several rapid breaths), hypoxaemia, muscle twitch or tremor or paddling, excitation, hypersalivation, retching, vomiting, urination, skin erythema, a sudden arousal, or prolonged sedation may occur.
Maltese: Meta dexmedetomidine u butarfanol jintużaw flimkien fil-klieb, jista' jkun hemm nifs bil-mod jew mgħaġġel, xejra respiratorja irregolari (20-30 sekonda qtugħ ta' nifs, segwiti minn ħafna nifsijiet mgħaġġla), nuqqas ta' ossiġnu fid-demm, ġibda jew rogħda fil-muskoli, qdif bir-riġlejn, eċċitament, tbeżliq, tqalligħ, remettar, tluq tal-urina, eritima tal-ġilda, tistembaħ f'daqqa jew irqad fit-tul.
English: 1 ml contains: Dexmedetomidine hydrochloride
Maltese: 1 ml fih: Dexmedetomidine hydrochloride
English: QUANTITY OF THE ACTIVE SUBSTANCE(S)
Maltese: TAS-SUSTANZA (I) ATTIVA (I)
English: *only IM
Maltese: *IM biss
English: In a clinical study, the requirement for propofol was reduced by 50%.
Maltese: Fi studju kliniku l-ammont ta' propofol li kien hemm bżonn tnaqqas b'50%.
English: It is recommended that animals are fasted for 12 hours prior to Cepedex administration.
Maltese: Huwa rakkomandat li l-annimali jkunu sajmin għal 12-il siegħa qabel jiġi amministrat Cepedex.
English: Shelf-life after first opening the container: 56 days.
Maltese: Jekk tiftaħ il-kontenitur jibqa' tajjeb għal: 56 jum.
English: Intramuscular dosing at 40 micrograms/kg (followed by ketamine or propofol) frequently resulted in sinus bradycardia and sinus arrhythmia, occasionally resulted in 1st degree atrioventricular block, and rarely resulted in supraventricular premature depolarizations, atrial bigeminy, sinus pauses, 2nd degree atrioventricular block, or escape beats/rhythms.
Maltese: Doża ta' 40 mikrogrammi/kg fil-muskolu (segwita minn ketamina jew propofol) spiss wasslet għal sinus bradycardia u sinus arrhythmia, kultant wasslet għal AV block tal-ewwel grad, u rari wasslet għal dipolarizzazzjonijiet supraventrikolari prematuri, atrial bigeminy, pawżi tas-sinus, AV block tat-tieni grad, jew battiti/ritmi maħrubin.
English: Cepedex 0.1 mg/ml injection dexmedetomidine hydrochloride
Maltese: Cepedex 0.1 mg/ml injezzjoni dexmedetomidine hydrochloride
English: Cepedex 0.5 mg/ml injection dexmedetomidine hydrochloride
Maltese: Cepedex 0.5 mg/ml injezzjoni dexmedetomidine hydrochloride
English: Advice to physicians: Cepedex is an α2-adrenoreceptor agonist, symptoms after absorption may involve clinical effects including dose-dependent sedation, respiratory depression, bradycardia, hypotension, a dry mouth, and hyperglycaemia.
Maltese: Cepedex huwa α2-adrenoreceptor agonist, sintomi wara assorbiment jistgħu jinvolvu effetti kliniċi inkluż sedazzjoni dipendenti fuq id-doża, dipressjoni respiratorja, bradikardja, pressjoni għolja b'mod anormali, ħalq xott, u ipergliċemija.
English: Cat Weight
Maltese: Piż tal
English: Rare instances of pulmonary oedema have been reported.
Maltese: Ġew irrapportati każijiet rari ta' edema pulmonari.
English: Corneal opacities may occur during sedation (see also section 4.5).
Maltese: Jista' jkun hemm ċpar fil-kornea waqt li traqqad (ara ukoll sezzjoni 4.5).
English: Cats: After a 40 micrograms/kg bw intramuscular dose the Cmax is 17 ng/ml.
Maltese: Wara doża ta' 40 mikrogrammi/kg piż fil-muskolu, is-Cmax hi ta' 17 ng/ml.
English: The stopper may be safely punctured up to 100 times.
Maltese: It-tapp jista' jittaqqab b'sigurtà sa 100 darba.
English: Solution for injection.
Maltese: Mhux applikabbli.
English: The premedication dose of dexmedetomidine is 125 - 375 micrograms/square metre body surface area, administered 20 minutes prior to induction for procedures requiring anaesthesia.
Maltese: Id-doża ta' premedikazzjoni ta' dexmedetomidine hija ta' 125 - 375 mikrogrammi/metru kwadru tal-wiċċ tal ġisem, mogħtija 20 minuta qabel jinbdew proċeduri li jeħtieġu l-anestesija.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (0.1 mg/ml)
Maltese: Kaxxa tal-kartun (0.1 mg/ml)
English: Marketing authorisation holder and manufacturer responsible for batch release: CP-Pharma Handelsgesellschaft mbH
Maltese: Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq u l-manifattur responsabbli għall-ħrug tal-lott CP Pharma Handelsgesellschaft mbH
English: Cardboard box pack sizes:
Maltese: Daqsijiet tal-pakkett tal-kaxex tal-kartun:
English: Pharmacotherapeutic group: Psycholeptics, hypnotics and sedatives ATCvet code: QN05CM18
Maltese: Psikoleptiċi, ipnotiċi u sedattivi Kodiċi ATC veterinarja:
English: Dexmedetomidine 40 micrograms/kg intramuscularly
Maltese: Dexmedetomidine 40 mcg/kg fil-muskolu
English: After concurrent exposure to an overdose of dexmedetomidine (3 times the recommended dose) and 15 mg ketamine/ kg, atipamezole can be administered at the recommended dose level for reversal of effects induced by dexmedetomidine.
Maltese: Wara li tingħata doża eċċessiva ta' dexmedetomidine (3 darbiet id-doża rakkomandata), flimkien ma' 15 mg ketamina/ kg, atimpamezole jista' tingħata fil-livell ta' doża rakkomandata biex treġġa' lura l-effetti ta' dexmedetomidine.