FrancophonIA/ELRC3.0 huggingface dataset:
English: Medicines for fits (seizures) (like phenytoin or phenobarbital) may decrease the effectiveness of vitamin D. Additional vitamin D supplements may be considered on an individual basis.
Maltese: Mediċini għallaċċessjonijiet (attakki ta' puplesija) (bħal phenytoin jew phenobarbital) jistgħu jnaqqsu l-effettività ta' vitamina D. Supplimenti addizjonali tal-vitamina D jistgħu jiġu kunsidrati fuq bażi individwali.
English: ADROVANCE is not recommended for patients with renal impairment where creatinine clearance is less than 35 ml/min, due to lack of experience.
Maltese: ADROVANCE m'huwiex irrakkomandat għal pazjenti b'indeboliment renali fejn it-tneħħija talkreatinina hija anqas minn 35 ml/min, minħabba nuqqas ta' esperjenza.
English: Vitamin D3 is required for normal bone formation.
Maltese: Vitamin D3 hi meħtieġa għal formazzjoni normali ta' l-għadam.
English: The bioavailability of the 5,600 IU vitamin D3 in ADROVANCE is similar to 5,600 IU vitamin D3 administered alone.
Maltese: Ilbijodisponibiltà tal-5600 IU vitamina D3 f'ADROVANCE hija simili għal 5600
English: Hypocalcaemia must be corrected before initiating therapy with ADROVANCE (see section 4.3).
Maltese: L-ipokalċemija għandha tiġi korretta qabel ma tinbeda t-terapija b'ADROVANCE (ara sezzjoni 4.3).
English: Also contains: lactose and sucrose.
Maltese: TA' EĊĊIPJENTI Fih ukoll: lactose u sucrose.
English: In this study, mean 25-hydroxyvitamin D levels in patients with vitamin D insufficiency at baseline (25-hydroxyvitamin D, 22.5 to 37.5 nmol/l [9 to < 15 ng/ml]) increased from 30 nmol/l (12.1 ng/ml) to 40 nmol/l (15.9 ng/ml) at week 15 in the ADROVANCE (70 mg/2,800 IU) group (n=75) and decreased from 30 nmol/l (12.0 ng/ml) at baseline to 26 nmol/l (10.4 ng/ml) at week 15 in the alendronate-only group (n=70).
Maltese: 9 ng/ml) f'ġimgħa 15 fil-grupp ADROVANCE (70 mg/2800 IU) (n=75) u naqsu minn 30 nmol/l (12.0 ng/ml) fil-linja bażi għal 26 nmol/l (10.4 ng/ml) f'ġimgħa 15 fil-grupp alendronate-biss (n=70).
English: The percentage of patients with vitamin D deficiency (serum 25-hydroxyvitamin D  22.5 nmol/l [ 9 ng/ml]) was significantly reduced by 92 % with ADROVANCE (70 mg/2,800 IU) vs. alendronate-only (1 % vs 13 %, respectively).
Maltese: [≤9 ng/ml]) kien sinifikattivament imnaqqas bi 92 % b'ADROVANCE (70 mg/2800 IU) kontra alendronate biss (1 % kontra 13 %, rispettivament).
English: Instruction Card
Maltese: Id-data ta'
English: • Patients should only swallow ADROVANCE whole.
Maltese: • Il-pazjenti għandhom jibilgħu biss pilloli ADROVANCE sħaħ.
English: España
Maltese: Danmark
English: ADROVANCE 70 mg/2,800 IU tablets Aluminium/aluminium blisters, in cartons containing 2, 4, 6 or 12 tablets.
Maltese: ADROVANCE 70 mg/2,800 IU pilloli huma disponibbli f'pakketti li fihom 2, 4, 6 jew
English: • FIT 2: A four-year study of 4,432 patients with low bone mass but without a baseline vertebral fracture.
Maltese: • FIT 2: Studju ta' erba' snin fuq 4,432 pazjenti b'massa ta' l-għadam baxx imma mingħajr fratturi vertebrali fil-linja bażi ta' riferiment.
English: The percentage of patients with vitamin D insufficiency was 5.4 % in the Vitamin D3 2,800 group vs. 3.2 % in the Vitamin D3 5,600 group through the 24-week extension.
Maltese: 3.2 % fil-grupp tal-Vitamina D3 5,600 matul l-estensjoni ta' 24 ġimgħa.
English: In patients with these conditions, serum calcium and symptoms of hypocalcaemia should be monitored during therapy with ADROVANCE.
Maltese: F'pazjenti b'dawn il-kundizzjonijiet, il-kalċju fis-serum u sintomi ta' ipokalċemija għandhom jiġu monitorjati waqt terapija b'ADROVANCE.
English: In this study, a significant difference was observed in the analysis of the subgroup of osteoporotic women (37 % of the global population who correspond with the above definition of osteoporosis) in the incidence of hip fractures (alendronate 1.0 % vs. placebo 2.2 %, a reduction of 56 %) and in the incidence of  1 vertebral fracture (2.9 % vs. 5.8 %, a reduction of 50 %).
Maltese: (alendronate 1.0 % kontra plaċebo 2.2 %, tnaqqis ta' 56 %) u fl-inċidenza ta' ≥1 frattura vertebrali (2.9 % kontra 5.8 %, tnaqqis ta' 50 %).
English: The bioavailability of the 2,800 IU vitamin D3 in ADROVANCE is similar to 2,800 IU vitamin D3 administered alone.
Maltese: Ilbijodisponibiltà tal-2800 IU vitamina D3 f'ADROVANCE hija simili għal 2800
English: Children and adolescents ADROVANCE should not be given to children and adolescents less than 18 years of age.
Maltese: Tfal u adolexxenti ADROVANCE ma għandux jingħata lil tfal u adolexxenti li għandhom anqas minn 18-il sena.
English: There is important additional information about how to take ADROVANCE in the package leaflet.
Maltese: L-ebda reazzjoni avversa addizzjonali ma ġiet identifikata għat-taħlita ta' alendronate u colecalciferol..
English: Each ADROVANCE 70 mg/5,600 IU tablet contains 70 mg alendronic acid (as sodium trihydrate) and 140 micrograms (5,600 IU) colecalciferol (vitamin D3).
Maltese: Kull pillola fiha 70 mg alendronic acid (bħala sodium trihydrate), u 140 mikrogramma (5600
English: ADROVANCE is not recommended for patients with renal impairment where creatinine clearance is less than 35 ml/min (see section 4.2).
Maltese: ADROVANCE mhux rakkomandat għal pazjenti b'indeboliment renali meta t-tneħħija tal-kreatinina hija anqas minn 35ml/min (ara sezzjoni 4.2).
English: ADROVANCE is a tablet containing the two active substances, alendronic acid (commonly called alendronate) and colecalciferol known as vitamin D3.
Maltese: ADROVANCE huwa pillola li fiha ż-żewġ sustanzi attivi, alendronic acid (magħruf b'mod komuni bħala alendronate) u colecalciferol magħruf bħala vitamina
English: In healthy adult subjects (males and females), following administration of ADROVANCE 70 mg/5,600 IU after an overnight fast and two hours before a meal, the mean area under the serumconcentration-time curve (AUC0-80 hrs) for vitamin D3 (unadjusted for endogenous vitamin D3 levels) was 490.2 ng•hr/ml.
Maltese: Wara l-għoti ta' pilloli ta' 70 mg/5,600 IU ADROVANCE f'suġġetti adulti b'saħħithom (irġiel u nisa) wara sawma tul il-lejl u sagħtejn qabel ikla, l-erja medja taħt il-kurva tal-konċentrazzjoni tas-serum mal-ħin (AUC0-120 hrs) għal vitamina D3 (mhux aġġustata għal-livelli ta' vitamina D3 endoġena) kienet ta' 490.2 ng•hr/ml.
English: ADROVANCE 70 mg/5,600 IU tablets Aluminium/aluminium blisters, in cartons containing 2, 4 or 12 tablets.
Maltese: ADROVANCE 70 mg/5,600 IU pilloli huma disponibbli f'pakketti li fihom 2, 4 jew 12
English: Each tablet contains 70 mg alendronic acid (as sodium trihydrate) and 70 micrograms (2,800 IU) colecalciferol (vitamin D3.
Maltese: Kull pillola fiha 70 mg alendronic acid (bħala sodium trihydrate) u 70 mikrogramma (2800
English: 200 ml), so that ADROVANCE is adequately absorbed.
Maltese: 200 ml), biex b'hekk ADROVANCE jiġi assorbit b'mod adegwat).
English: The principal action of 1,25-dihydroxyvitamin D3 is to increase intestinal absorption of both calcium and phosphate as well as regulate serum calcium, renal calcium and phosphate excretion, bone formation and bone resorption.
Maltese: L-azzjoni prinċipali ta' 1,25-dihydroxyvitamin D3 hija li żżid l-assorbiment intestinali kemm tal-kalċju u l-fosfat kif ukoll li tirregola l-kalċju fis-serum, il kalċju renali u l-eliminazzjoni tal-fosfat, il-formazzjoni ta' l-għadam u l-assorbiment mill-ġdid ta' lgħadam.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Maltese: Informazzjoni mhux klinika magħmula fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il-ġeni, riskju ta' kanċer, ma' turi l-ebda periklu speċjali għall-bnedmin.
English: In healthy adult subjects (males and females), following administration of ADROVANCE 70 mg/2,800 IU tablets after an overnight fast and two hours before a meal, the mean area under the serum-concentration-time curve (AUC0-120 hrs) for vitamin D3 (unadjusted for endogenous vitamin D3 levels) was 296.4 ng•hr/ml.
Maltese: Wara l-għoti ta' pilloli ta' 70 mg/2,800 IU ADROVANCE f'suġġetti adulti b'saħħithom (irġiel u nisa) wara sawma tul il-lejl u sagħtejn qabel ikla, l-erja medja taħt il-kurva tal-konċentrazzjoni tas-serum mal-ħin (AUC0-120 hrs) għal vitamina D3 (mhux aġġustata għal-livelli ta' vitamina D3 endoġena) kienet ta' 296.4 ng•hr/ml.
English: ADROVANCE is indicated for the treatment of postmenopausal osteoporosis in women at risk of vitamin D insufficiency.
Maltese: ADROVANCE huwa indikat għat-trattament ta' l-osteoporożi ta' wara l-menopawsa f'nisa li jinsabu f'riskju minn insuffiċjenza ta' vitamina D.
English: Because there is a potential for worsening of the underlying disease, caution should be used when alendronate is given to patients with active upper gastrointestinal problems, such as dysphagia, oesophageal disease, gastritis, duodenitis, ulcers, or with a recent history (within the previous year) of major gastrointestinal disease such as peptic ulcer, or active gastrointestinal bleeding, or surgery of the upper gastrointestinal tract other than pyloroplasty (see section 4.3).
Maltese: Minħabba li hemm il-potenzjal għal deterjorament tal-marda prinċipali, għandha tintuża l-kawtela meta alendronate jingħata lil pazjenti bi problemi gastrointestinali attivi tan-naħa ta' fuq, bħal disfaġja, mard ta' l-esofaġu, gastrite, duwodenite, ulċeri, jew bi storja riċenti (fi żmien l-aħħar sena) ta' mard gastrointestinali maġġur bħal ulċeri peptiċi, jew emorraġiji gastrointestinali attivi, jew kirurġija fuq ilpassaġġ gastrointestinali tan-naħa ta' fuq ħlief għal piloroplasti (ara sezzjoni 4.3).
English: Ear and labyrinth disorders
Maltese: Pazjenti b'indeboliment renali
English: Therefore, patients must wait at least 30 minutes after taking alendronate before taking any other oral medicinal product (see sections 4.2 and 5.2).
Maltese: Għalhekk, il-pazjenti għandhom jistennew ta' l-anqas 30 minuta wara li jieħdu alendronate qabel ma jieħdu xi prodott medicinali orali ieħor (ara sezzjoni 4.2 u 5.2).
English: ADROVANCE 70 mg/2,800 IU tablets ADROVANCE 70 mg/5,600 IU tablets
Maltese: Informazzjoni għall-utent ADROVANCE 70 mg/2800 IU pilloli
English: Each ADROVANCE 70 mg/2,800 IU tablet contains 70 mg alendronic acid (as sodium trihydrate) and 70 micrograms (2,800 IU) colecalciferol (vitamin D3).
Maltese: Kull pillola fiha 70 mg alendronic acid bħala (sodium trihydrate), u 70 mikrogramma (2800
English: The therapeutic equivalence of alendronate once weekly 70 mg (n=519) and alendronate 10 mg daily (n=370) was demonstrated in a one-year multicentre study of post-menopausal women with osteoporosis.
Maltese: 10 mg kuljum (n=370) kienet murija fi studju ta' sena f'ċentri multipli fuq nisa wara l-menopawża blosteoporożi.
English: Insufficiency is associated with negative calcium balance, bone loss, and increased risk of skeletal fracture.
Maltese: L-insuffiċjenza hija assoċjata ma' bilanċ tal-kalċju negattiv, telf ta' l-għadma, u riskju aktar ta' fratturi skeletriċi.
English: If you stop taking ADROVANCE
Maltese: Tiħux ADROVANCE
English: The mean half-life of vitamin D3 in the serum following an oral dose of ADROVANCE (70 mg/2,800 IU) is approximately 24 hours.
Maltese: Il-half-life medja ta' vitamina D3 fis-serum wara doża orali ta' ADROVANCE (70 mg/2800
English: It is very important to follow instructions 2), 3), 4) and 5) to help the ADROVANCE tablet reach your stomach quickly and help reduce the chance of irritating your gullet (oesophagus - the tube that connects your mouth with your stomach).
Maltese: Huwa importanti ħafna li ssegwi l-istruzzjonijiet 2), 3), 4) u 5) sabiex tgħin il-pillola ta' ADROVANCE tilħaq 'l-istonku tiegħek malajr u sabiex jitnaqqas iċ-ċans li hija tirritalek il-passaġġ mill-griżmejn sal-istonku (esofagu - it-tubu li jgħaqqad 'il ħalqek ma l-istonku).
English: ADROVANCE tablet whole with a full glass of water only (not mineral water) (not less than
Maltese: ADROVANCE tiegħek sħiħa ma' tazza mimlija ilma (mhux ilma minerali) (mhux inqas minn
English: Patients received the lower strength (70 mg/2,800 IU) of ADROVANCE (n=350) or FOSAMAX (alendronate) 70 mg (n=332) once a week; additional vitamin D supplements were prohibited.
Maltese: (alendronate) 70 mg (n=332)darba fil ġimgħa; supplimenti addizzjonali ta' vitamina D kienu projbiti.
English: • Use of antibiotics
Maltese: • Użu ta' antibijotiċi
English: • Key signs and symptoms of IVT injection related adverse events including increased intraocular pressure, glaucoma, ocular hypertension, cataract, traumatic cataract related to injection technique, vitreous detachment, vitreous haemorrhage, endophthalmitis,
Maltese: • Sinjali ewlenin u sintomi għal avvenimenti avversi marbuta mal-injezzjoni tal-IVT, li jinkludu żieda fil-pressjoni intraokulari, glawkoma, pressjoni għolja fl-għajnejn, kataretti, kataretta trawmatika marbuta mat-teknika tal-injezzjoni, qtugħ vitreuż, emorraġija vitreuża, endoftalmite, qtugħ fir-retina, tiċrita fir-retina, falliment mekkaniku tal-apparat u tqegħid ħażin tal-impjant.
English: • Techniques for the intravitreal injection
Maltese: • Tekniċi għall-injezzjoni intravitreali
English: The Member States shall ensure that the provision of educational material implemented for the authorised indication of treatment of adult patients with macular oedema following either Branch Retinal Vein Occlusion (BRVO) or Central Retinal Vein Occlusion (CRVO), is extended to the potential prescribers concerned by the new indication: treatment of adult patients with inflammation of the posterior segment of the eye presenting as non-infectious uveitis.
Maltese: L-Istati Membri għandhom jiżgura li l-forniment tal-materjal edukattiv implimentat għall-indikazzjoni awtorizzata ta' kura ta' pazjenti adulti b'edema makulari wara jew Okklużjoni ta' Vina Sekondarja tarRetina (BRVO) jew Okklużjoni ta' Vina Ċentrali tar-Retina (CRVO), jiġi estiż għal dawk il-persuni li potenzjalment jistgħu jagħtu riċetta fir-rigward tal-indikazzjoni l-ġdida: il-kura ta' pazjenti adulti b'infjammazzjoni tas-segment ta' wara tal-għajnejn li tidher bħala uveite mhux infettiva.
English: • Aseptic techniques to minimise the risk of infection
Maltese: • Tekniċi asettiċi li jnaqqsu r-riskju ta' infezzjoni
English: • Patient information leaflet
Maltese: • Pakkett ta' informazzjoni lill-pazjent
English: • Patient information pack
Maltese: • Informazzjoni lit-tabib
English: • Management of IVT injection related adverse events The patient information pack should be provided in both the form of patient information booklet and an audio-CD that contain following key elements:
Maltese: Il-pakkett ta' informazzjoni lill-pazjent għandu jiġi pprovdut kemm fis-sura ta' fuljett ta' informazzjoni lill-pazjent u bħala awdjo-CD li jkun fiha l-informazzjoni ewlenija li ġejja:
English: • What are the steps following treatment with Ozurdex
Maltese: • X'inhuma l-istadji wara l-kura b'Ozurdex
English: The Member States shall agree the final educational material with the Marketing Authorisation Holder (MAH) prior to launch of the new indication in their territory.
Maltese: L-Istati Membri għandhom jiftehmu dwar il-materjal edukattiv finali mad-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) qabel it-tnedija tal-indikazzjoni ġdida fit-territorju tagħhom.
English: • Intravitreal injection procedure pictogram
Maltese: • Piktogramm dwar il-proċedura tal-injezzjoni intravitreali
English: The educational material contains the following:
Maltese: Il-materjal edukattiv fih dan li ġej:
English: • Patient monitoring after IVT injection
Maltese: • Monitoraġġ tal-pazjent wara l-injezzjoni IVT
English: • Intravitreal injection procedure video
Maltese: • Vidjo dwar il-proċedura tal-injezzjoni intravitreali
English: • How to prepare for Ozurdex treatment
Maltese: • Kif tipprepara għall-kura b'Ozurdex
English: • Key signs and symptoms of serious adverse events including increased intraocular pressure and ocular hypertension
Maltese: • Sinjali u sintomi ewlenin ta' avvenimenti avversi serji li jinkludu żieda fil-pressjoni ġol għajnejn u pressjoni għolja fl-għajnejn
English: 80 doses
Maltese: 80 doża
English: p-value C-2001-011 27 % (64/235) 57 % (116/204) <0.0001
Maltese: valur-p C-2001-011 27 % (64/235) 57 % (116/204) <0.0001
English: Placebo n=273
Maltese: Plaċebo n=273
English: IV-PCA (morphine) n=1298
Maltese: IV-PCA (morfina) n=1298
English: The mean systemic bioavailability is 87%.
Maltese: Ilbijodisponibbiltà sistemika hija ta' 87 %.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1050/001
Maltese: EU/1/15/1050/001
English: Tel: +44 (0)800 587 4149 or +44 (0)203 684 6344 Email: medical.information@themedco.com
Maltese: Tel: +44 (0)800 587 4149 jew +44 (0)203 684 6344
English: Tolerance, physical dependence, and psychological dependence may develop upon repeated administration of opioids.
Maltese: Tolleranza, dipendenza fiżika, u dipendenza psikoloġika jistgħu jiżviluppaw b'għoti ripetut ta' opjojdi.
English: (86/1436 or 6%) showed no meaningful difference relative to patients with BMI ≤ 40.
Maltese: (86/1436 jew 6 %) ma wera ebda differenza sinifikanti relattiva għall-pazjenti b'BMI ≤ 40.
English: All adverse reactions are listed by System Organ Class and frequency: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); and rare (≥1/10,000
Maltese: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); u rari (≥1/10,000 sa <1/1,000).
English: The plasma protein binding of fentanyl is 80% to 85%.
Maltese: L-irbit tal-proteina tal-plażma ta' fentanyl huwa ta' bejn 80 % u 85 %.
English: Incline Therapeutics Europe Ltd 21 St. Thomas Street Bristol
Maltese: Incline Therapeutics Europe Ltd 21 St.
English: Abuse potential and dependence
Maltese: Potenzjal ta' abbuż u dipendenza
English: Pharmacotherapeutic group: Analgesics; phenylpiperidine derivatives; ATC code: N02AB03.
Maltese: Analġeżiċi; derivati ta' phenylpiperidine; kodiċi ATC: N02AB03. Mekkaniżmu ta' azzjoni
English: • Each dose will last for 10 minutes.
Maltese: • Kull doża ser tieħu 10 minuti.
English: Physical status
Maltese: Status fiżiku
English: Its secondary pharmacological effects are respiratory depression, bradycardia, hypothermia, constipation, miosis, physical dependence and euphoria (see section 5.2).
Maltese: L-effetti farmakoloġiċi sekondarji tiegħu huma dipressjoni respiratorja, bradikardija, ipotermja, stitikezza, mijożi, dipendenza fiżika u ewforija (ara sezzjoni 5.2).
English: There are 6 systems per carton.
Maltese: Hemm 6 sistemi għal kull kartuna.
English: The assembled IONSYS product measures 47 mm x 75 mm.
Maltese: Ilprodott IONSYS meta assemblat għandu qisien ta' 47 mm x 75 mm.
English: Table 2 Active Comparator Trials (n=2569) Evaluable Patients
Maltese: Tabella 2 Pazjenti Evalwabbli (n=2569) fi Provi ta' Komparatur Attiv
English: • tightness/tension in muscles, muscle pain
Maltese: • tagħfis/tensjoni fil-muskoli, uġigħ fil-muskoli
English: Chronic pulmonary disease
Maltese: Disturbi pulmonari
English: Probable cause
Maltese: Kawża probabbli
English: Bradychardia
Maltese: Bradikardija
English: Concomitant use of analgesics was not allowed after 3 hours in Studies C-2000-007 and CAPSS-320.
Maltese: L-użu konkomitanti ta' analġeżiċi ma kienx permess wara 3 sigħat fl-Istudji C-2000-007 u CAPSS-320.
English: • low calcium/glucose/potassium in blood serum
Maltese: • kalċju/glukożju/potassju baxx fis-serum tad-demm
English: Obese patients In the controlled clinical trial population, the adverse reaction profile in patients with BMI > 40
Maltese: F'popolazzjoni ta' prova klinika kkontrollata, il-profil tar-reazzjonijiet avversi fil-pazjenti b'BMI > 40
English: • you are taking medicines for depression called monoamine-oxidase (MAO) inhibitors.
Maltese: • qed tieħu mediċini għad-dipressjoni msejħin inibituri ta' monoamine-oxidase (MAO).
English: Paralytic ileus
Maltese: Ileus paralitiku
English: Name and address of the manufacturer responsible for batch release Penn Pharmaceutical Services Ltd 23-24 Tafarnaubach Industrial Estate Tredegar
Maltese: Penn Pharmaceutical Services Ltd 23-24 Tafarnaubach Industrial Estate Tredegar
English: • Blinking display number
Maltese: • Numru jteptep fuq id-displej
English: 5.6%)a, b 7.4%)a, b 4.0%)a, b a 95% Confidence Interval for difference in proportions The pre-specified equivalence boundary was ± 10%
Maltese: (-9.7%, 3.7%)a, b (-4.7%, 5.6%)a, b (-5.1%, 7.4%)a, b (-6.2%, 4.0%)a, b
English: 1 system contains fentanyl hydrochloride equivalent to 9.7 mg of fentanyl.
Maltese: Sistema waħda fiha fentanyl hydrochloride ekwivalenti għal 9.7 mg ta' fentanyl.
English: The use of concomitant CNS-active medicinal products may increase the risk of respiratory depression (see section 4.5).
Maltese: L-użu ta' prodotti mediċinali attivi tas-CNS konkomitanti jista' jżid ir-riskju ta' dipressjoni respiratorja (ara sezzjoni 4.5).
English: No overall differences were observed in the safety of IONSYS fentanyl 40 micrograms in elderly patients (≥ 65 years including a subpopulation ≥ 75 years) and adult patients for all controlled studies.
Maltese: Ma ġiet osservata ebda differenza fis-sigurtà ta' IONSYS fentanyl 40 mikrogramma f'pazjenti anzjani (≥65 sena inkluż subpopolazzjoni ta' pazjenti ≥75 sena) u l-pazjenti adulti għall istudji kkontrollati kollha.
English: Each IONSYS carton contains 6 systems.
Maltese: Kull kartuna ta' IONSYS fiha 6 sistemi.
English: • Steady display number
Maltese: • Numru kostanti fuq id-displej
English: Gastrointestinal disorder therapy
Maltese: Terapija għal disturb gastrointestinali
English: Another published article of 52 elderly Japanese post-operative patients receiving continuous intravenous (IV) fentanyl infusion (0.5-1.5 µg/kg/h) showed increased fentanyl exposure in the CYP3A5*3 group (3*/3*) than in the 1* carrier group.
Maltese: Artiklu ieħor ippubblikat ta' 52 pazjent Ġappuniż anzjan wara operazzjoni li kienu qegħdin jirċievu infużjoni kontinwa ġol-vina (IV) ta' fentanyl (0.51.5 µg/kg/siegħa) urew żieda fl-espożizzjoni għal fentanyl fil-grupp ta' CYP3A5*3 (3*/3*) milli filgrupp tat-trasportatur 1*.
English: The active substance in IONSYS is fentanyl hydrochloride.
Maltese: X'fih IONSYS Is-sustanza attiva f'IONSYS hija fentanyl hydrochloride.
English: The mean amount of supplemental opioid used during this time was also similar among patients treated with IONSYS or PCA morphine i.e. a range across the 4 studies of a mean dose of 5.0 - 7.5 mg morphine in patients treated with IONSYS compared to a mean dose of 5.4 - 7.7mg morphine in patients receiving PCA morphine.
Maltese: L-ammont medju ta' opjojdi supplimentali użat matul dan il-ħin kienet simili bejn il-pazjenti kkurati b'IONSYS jew morfina PCA jiġifieri medda fl-4 studji kollha ta' doża medja ta' 5.0 - 7.5 mg ta' morfina f'pazjenti kkurati b'IONSYS meta mqabbel mad-doża medja ta' 5.47.7 mg ta' morfina f'pazjenti li jirċievu morfina PCA.
English: • you are taking medicines for bacterial infections (such as troleandomycin, clarithromycin or
Maltese: • qed tieħu mediċini għal infezzjonijiet batterjali (bħal troleandomycin, clarithromycin jew
English: Study C-2000-007 evaluated patients after undergoing abdominal, thoracic, or orthopedic surgeries; Study CAPSS-319 evaluated patients after undergoing total hip replacement; Study CAPSS-320 assessed IONSYS in patients following abdominal and pelvic surgeries; and Study FEN-PPA-401 assessed patients following major abdominal or orthopedic surgery.
Maltese: L-Istudju C-2000-007 evalwa l pazjenti wara li għaddew minn operazzjonijiet addominali, toraċiċi jew ortopediċi; l-Istudju CAPSS319 evalwa l-pazjenti wara li saritilhom kirurġija ta' bdil totali tal-ġenbejn; Studju CAPSS-320
English: Hypocalcaemia Hypoglycaemia Hypokalaemia
Maltese: Ipokalċimija Ipogliċemija
English: Patients with genetic polymorphisms affecting CYP3A4 and CYP3A5
Maltese: Pazjenti b'polimorfiżmi ġenetiċi li jaffettwaw CYP3A4 u CYP3A5
English: Apnoea
Maltese: Apnea
English: • you are taking medicines for HIV infection (such as ritonavir, nelfinavir, amprenavir or
Maltese: • qed tieħu mediċini għal infezzjoni tal-HIV (bħal ritonavir, nelfinavir, amprenavir jew