FrancophonIA/ELRC3.0 huggingface dataset:
English: Cardiovascular death and stroke were both numerically more frequent in the aliskiren group that in the placebo group and adverse events and serious adverse events of interest (hyperkalaemia, hypotension and renal dysfunction) were more frequently reported in the aliskiren group than in the placebo group.
Maltese: Mewt kardjovaskulari u puplesija t-tnejn kienu numerikament iktar frekwenti filgrupp ta' aliskiren milli fil-grupp tal-plaċebo, u avvenimenti avversi u avvenimenti avversi serji ta' interess (iperkalimja, pressjoni baxxa u disfunzjoni tal-kliewi) ġew irrappurtati b'mod iktar frekwenti fil-grupp ta' aliskiren milli fil-grupp tal-plaċebo.
English: NAME OF THE MEDICINAL PRODUCT Karvea 150 mg tablets.
Maltese: Karvea 150 mg pilloli.
English: EU/1/97/049/004-006 EU/1/97/049/011 EU/1/97/049/014
Maltese: EU/1/97/049/011 EU/1/97/049/014
English: NAME OF THE MEDICINAL PRODUCT Karvea 75 mg tablets irbesartan STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains: irbesartan 75 mg LIST OF EXCIPIENTS Excipients: also contains lactose monohydrate.
Maltese: Karvea 75 mg pilloli irbesartan DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I)
English: Each tablet of Karvea 150 mg contains 150 mg irbesartan.
Maltese: Kull pillola miksija b'rita fiha 150 mg irbesartan.
English: What Karvea looks like and contents of the pack Karvea 75 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2871 engraved on the other side.
Maltese: Il-pilloli Karvea 75 mg huma bojod għal offwajt, ibbuzzati fuq iż-żewġ naħat, ovali, b'qalb stampata fuq naħa waħda u n-numru 2871 imnaqqax fuq in-naħa l-oħra.
English: What Karvea looks like and contents of the pack Karvea 150 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2772 engraved on the other side.
Maltese: Il-pilloli Karvea 150 mg huma bojod għal offwajt, ibbuzzati fuq iż-żewġ naħat, ovali, b'qalb stampata fuq naħa waħda u n-numru 2772 imnaqqax fuq in-naħa l-oħra.
English: The demonstration of renal benefit of Karvea in hypertensive type 2 diabetic patients is based on studies where irbesartan was used in addition to other antihypertensive agents, as needed, to reach target blood pressure (see sections 4.3, 4.4, 4.5 and 5.1).
Maltese: Il-benefiċċju renali muri b'Karvea f'pazjenti b'dijabete ta' tip 2 li għandhom pressjoni għolja huwa bbażat fuq studji fejn irbesartan intuża flimkien ma' mediċini oħra ta' kontra l-pressjoni għolja kif meħtieġ, biex jintlaħaq il-livell mixtieq ta' pressjoni (ara sezzjonijiet 4.3, 4.4, 4.5 u 5.1).
English: Reproductive system and breast disorders Uncommon: sexual dysfunction
Maltese: tromboċitopenija Disturbi tas-sistema immuni
English: NAME OF THE MEDICINAL PRODUCT Karvea 300 mg tablets.
Maltese: Karvea 300 mg pilloli.
English: Karvea belongs to a group of medicines known as angiotensin-II receptor antagonists.
Maltese: Karvea jappartjeni għall-grupp ta' mediċini magħrufa bħala antagonisti tar-riċetturi angiotensin-II.
English: Package leaflet: Information for the user Karvea 300 mg tablets irbesartan
Maltese: Informazzjoni għall-utent Karvea 300 mg pilloli irbesartan
English: Metabolism and nutrition disorders
Maltese: Disturbi gastro-intestinali
English: NAME OF THE MEDICINAL PRODUCT Karvea 300 mg tablets irbesartan NAME OF THE MARKETING AUTHORISATION HOLDER sanofi-aventis groupe EXPIRY DATE
Maltese: Bħal fil-każi ta' prodotti mediċinali oħra li jaffettwaw is-sistema renin-angiotensin, pazjenti suwed bi pressjoni għolja wrew ferm inqas respons għal monoterapija b'irbesartan.
English: NAME OF THE MEDICINAL PRODUCT Karvea 150 mg tablets irbesartan STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains: irbesartan 150 mg LIST OF EXCIPIENTS Excipients: also contains lactose monohydrate.
Maltese: Karvea 150 mg pilloli irbesartan DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I)
English: NAME OF THE MEDICINAL PRODUCT Karvea 150 mg tablets irbesartan NAME OF THE MARKETING AUTHORISATION HOLDER sanofi-aventis groupe EXPIRY DATE
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq:: sanofi-aventis groupe
English: Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with Karvea (see section 4.4).
Maltese: Kura li ssir qabel b'dożi għoljin ta' dijuretiċi tista' tirriżulta f'nuqqas fil-volum u riskju ta' pressjoni baxxa meta tinbeda l-kura b'Karvea (ara sezzjoni 4.4).
English: Renal impairment and kidney transplantation: when Karvea is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended.
Maltese: Indeboliment renali u trapjant tal-kliewi: meta Karvea jintuża f'pazjenti b'indeboliment renali, hija irrikmandata osservanza perjodika tal-livelli tal-potassju u tal-krejatinina fis-serum.
English: Energy (keV)*
Maltese: Enerāija (keV)*
English: GBq/vial,
Maltese: GBq/kunjett,
English: ATC Code: V10BX02
Maltese: V10BX02
English: Effective dose (mSv/MBq)
Maltese: DoŜa effettiva (mSv/MBq)
English: Manufacturer: CIS bio international.
Maltese: CIS bio international.
English: EXP: DD/MM/YYYY (12 h CET)
Maltese: DD/MM/YYYY (12 h CET)
English: Excipient with known effect: sodium 8.1 mg/mL.
Maltese: Eëëipjent b'effett magħruf: sodium 8.1 mg/ml
English: • Hypersensitivity to the active substance (ethylenediaminetetramethylenephosphonate (EDTMP)
Maltese: • Sensittività eëëessiva għas-sustanza attiva (ethylenediaminemethylenephosphonate (EDTMP))
English: MARKETING AUTHORISATION NUMBER EU/1/97/057/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/97/057/001
English: TABLE 2 : RADIATION ABSORBED DOSES
Maltese: TABELLA 2 : DOśI ASSORBITI
English: (Corresponding to 20 to 80 µg/ml of samarium)
Maltese: (Li tikkorrespondi għal 20 sa 80 µg/ml ta' samarium)
English: At 4 and 24 hours, plasma radioactivity had decreased from 1.3 ± 0.7 % to 0.05 ± 0.03 %.
Maltese: F'4 u 24 siegħa, ir-radjuattività naqset minn 1.3 ± 0.7 % għal 0.05 ± 0.03 %.
English: 6.1 List of excipients
Maltese: 6.1 Lista ta' eëëipjenti
English: Pharmacodynamic effects
Maltese: Effetti Farmakodinamiëi
English: Non-radioactive Sm-EDTMP showed no mutagenic potential in a battery of in vivo and in vitro tests.
Maltese: Sm-EDTMP mhux radjuattiv ma wera ebda potenzjali mutaāeniku fi provi in vivo u in vitro.
English: At 12 hours, 35.3 ± 13.6 % of the administered activity had been excreted into the urine.
Maltese: Wara 12-il siegħa, 35.3 ± 13.6 % tal-attività li ngħatat āiet eliminata fl-awrina.
English: Absorbed dose per injected activity (mGy/MBq)
Maltese: DoŜa assorbita minn kull attività injettata (mGy/MBq)
English: Clinical efficacy and safety
Maltese: Effikaëja klinika u sigurtà
English: (corresponding to 20-80 µg/ml of samarium per vial).
Maltese: (li jikkorispondi għal 20-80 µg/ml of samarium kull kunjett)
English: Date of latest renewal: 12 December 2007
Maltese: Data tal-aħħar tiādid: 05 Frar 2007
English: 91192 GIF-SUR-YVETTE Cedex, FRANCE
Maltese: 91192 GIF-SUR-YVETTE Cedex, FRANZA
English: Gamma * Maximum energies are listed for the beta emissions, the average beta particle energy is
Maltese: Gamma * L-enerāiji massimi huma elenkati għall-emissjonijiet beta, l-enerāija medja tal-partikula beta hija ta' 233 keV.
English: • in pregnant women (See section 4.6).
Maltese: • f'nisa tqal (ara sezzjoni 4.6).
English: Urinary excretion occurred predominantly during the first 4 hours (30.3 ± 13.5 %).
Maltese: L-eliminazzjoni fl-awrina seħħet primarjament matul l-ewwel 4 sigħat (30.3 ± 13.5 %).
English: For the full list of excipients, see section 6.1.
Maltese: Għal-lista kompluta ta' eëëipjenti, ara sezzjoni 6.1
English: How to store Quadramet
Maltese: Tieħux Quadramet
English: (See section 12, for detailed instructions of product preparation)
Maltese: (Ara sezzjoni 12, għal informazzjoni dettaljata dwar il-preparazzjoni tal-prodott)
English: F-91192 GIF-SUR-YVETTE Cedex FRANCE
Maltese: F-91192 GIF-SUR-YVETTE Cedex FRANZA
English: TABLE 1 : SAMARIUM-153 PRINCIPAL RADIATION EMISSION DATA Radiation
Maltese: TABELLA 1: SAMARIUM-153 DATA TA' EMISSJONI TA' RADJAZZJONI PRINêIPALI
English: Abundance
Maltese: Abbundanza
English: Quadramet has a high affinity for skeletal tissue.
Maltese: Quadramet għandu affinità għolja għat-tessut skeletali.
English: Clear, colourless to light amber solution with pH ranging between 7.0 and 8.5.
Maltese: Soluzzjoni ëara, mingħajr kulur għal ambra ëar b'pH li jvarja nejn 7.0 u 8.5.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 1.3 GBq Samarium (153Sm) lexidronam pentasodium at the reference date (corresponding to 20 to 80 µg/ml of samarium per vial) Samarium specific activity is approximately 16 - 65 MBq/µg of samarium.
Maltese: U KWANTITATTIVA :Kull ml ta' soluzzjoni fih 1.3 GBq Samarium (153Sm) lexidronam pentasodium fid-data ta' referenza (li tikkorrespondi għal 20 sa 80 µg/ml ta' samarium għal kull kunjett) Attività speëifika għal samarium hi madwar 16 - 65
English: Total skeletal uptake of Quadramet in studies of 453 patients with a variety of primary malignancies was 65.5 ± 15.5 % of the administered activity.
Maltese: It-teħid skeletriku totali ta' Quadramet fi studji fuq 453 pazjent b'diversi malinni prinëipali kien ta' 65.5 ± 15.5 % tal-attività mogħtija.
English: In contrast, skeletal uptake was inversely proportional to plasma radioactivity at 30 minutes.
Maltese: B'kuntrast it-teħid skeletriku kien proporzjonalment invers għar-radjuattività fil-plaŜma għal 30 minuta.
English: Thirty minutes after injection of the agent to 22 patients, only 9.6 ± 2.8 % of the administered activity remained in plasma.
Maltese: Tletin minuta wara l-injezzjoni ta' Quadramet lil 22 pazjent, 9.6 ± 2.8 % biss tal-attività li ngħatat baqgħet fil-plaŜma.
English: 1.3 GBq/ml at reference date.
Maltese: 1.3 GBq/ml fid-data tal-kalibrar.
English: In rare cases, the following undesirable effects have been observed: neuralgia, coagulation disorders, cerebrovascular accidents.
Maltese: F'kaŜijiet rari, āew osservati l-effetti mhux mixtieqa li āejjin: nevralāija, problemi fil-koagulazzjoni u aëëidenti ëerebrovaskulari.
English: Store at -10°C to -20°C in a freezer in its original packaging.
Maltese: AħŜen f'temperatura ta' -10°C sa -20°C fi friŜa fil-pakkett oriāinali tiegħu.
English: 1 day from the activity reference time stated on the label.
Maltese: Āurnata mill-ħin ta' referenza tal-attività mogħti fuq it-tikketta.
English: Quadramet 1.3 GBq/mL solution for injection
Maltese: Quadramet 1.3GBq/ml soluzzjoni għall-injezzjoni
English: For instructions on preparation of the medicinal product before administration, see section 12.
Maltese: Għall-istruzzjonijiet dwar il-preparazzjoni tal-prodott mediëinali qabel ma jingħata, ara sezzjoni 12.
English: INFORMATION IN BRAILLE <Justification for not including Braille accepted>
Maltese: INFORMAZZJONI BIL-BRAILLE <Il-āustifikazzjoni biex ma jkunx inkluŜ il-Braille hija aëëettata.>
English: STATEMENT OF ACTIVE SUBSTANCE(S) Samarium (153Sm) lexidronam pentasodium :
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Samarium (153Sm) lexidronam pentasodium :
English: Samarium-153 emits both medium-energy beta particles and an imageable gamma photon, and has a period of 46.3 hours (1.93 days).
Maltese: Samarium-153 jarmi kemm partikuli beta ta' enerāija medja kif ukoll foton gamma li jista' jsir xbieha, u għandu perijodu ta' 46.3 sigħat (1.93 āranet).
English: For this product the effective dose resulting from an injected activity of 2 590 MBq is 796 mSv.
Maltese: MBq hija ta' 796 mSv.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediëina tinsab fuq il-website tal-Aāenzija Ewropea dwar ilMediëini http://www.ema.europa.eu.
English: The active substance is samarium (153Sm) lexidronam pentasodium.
Maltese: Is-sustanza attiva hi samarium (153Sm) lexidronam pentasodium.
English: NAME OF THE MEDICINAL PRODUCT Quadramet 1.3 GBq/mL solution for injection Samarium (153Sm) lexidronam pentasodium
Maltese: Quadramet,1.3 GBq/ml soluzzjoni għall-injezzjoni Samarium (153Sm) lexidronam pentasodium
English: Total EDTMP (as EDTMP.H2O) Calcium-EDTMP sodium salt (as Ca) Total sodium (as Na) Water for injections
Maltese: EDTMP totali (bħala EDTMP.H2O) Calcium-EDTMP sodium salt (bħala Ca) Sodju totali (bħala Na) Ilma għall-injezzjonijiet
English: The possibility of pharmacological overdose is therefore remote.
Maltese: Il-possibilità ta' doŜa farmakoloāika eëëessiva hija għalhekk remota.
English: Gallbladder Ascending colon wall Descending colon wall Small intestine Myocardial wall Kidneys
Maltese: Ir-riti tal-kolon li telgħin 'l fuq Ir-riti tal-kolon li nieŜlin 'l isfel Il-musrana Ŝ-Ŝgħira Ir-rita mijokardijaka Kliewi
English: Quadramet is not recommended for use in children below the age of 18 years due to a lack of data on safety and efficacy.
Maltese: Quadramet mhux rakkomandat għal uŜu fi tfal li għadhom taħt it-18-il sena minħabba nuqqas ta' informazzjoni dwar is-sigurtà u l-effikaëja.
English: or similar phosphonates) or to any of the excipients excipients listed in section 6.1.
Maltese: jew phosphonates simili) jew għal kwalunkwe wieћed mill-eëëipjenti elenkati fis-sezzjoni 6.1.
English: Each vial contains 1.5 ml (2 GBq at calibration) to 3.1 ml (4 GBq at calibration) of solution for injection.
Maltese: Kull kunjett fih 1.5 ml (2 GBq waqt il-kalibrazzjoni) sa 3.1 ml (4
English: It should not be used concurrently with other biphosphonates if an interference is shown on the technetium (99mTc)-labelled biphosphonate bone scans.
Maltese: Il-preŜenza ta' metastasi ostejoblastika li tieħu biphosphonates immarkati b'sustanza radjuattiva ta' technetium (99mTc) għandha tiāi kkonfermata qabel it-terapija.
English: Hypersensitivity reactions including rare cases of anaphylactic reaction have been reported after Quadramet administration.
Maltese: Reazzjonijiet ta' sensittività eëëessiva li jinkludu kaŜijiet rari ta' reazzjoni anafilattika āew irrapportati wara li ngħata Quadramet.
English: Total EDTMP (as EDTMP.H2O) Calcium-EDTMP sodium salt (as Ca) Total sodium (as Na) Water for Injections
Maltese: EDTMP totali (bħala EDTMP.H2O) Calcium-EDTMP sodium salt (bħala Ca) Sodju totali (bħala Na) Ilma għall-injezzjonijiet.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION Date of first authorisation: 05 February 1998
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĀDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 05 Frar 1998
English: Quadramet expires 1 day from the activity reference time stated on the label.
Maltese: Quadramet jiskadi wara āurnata miŜ-Ŝmien ta' referenza tal-attività indikat fuq it-tikketta.
English: A positive correlation was found between skeletal uptake and the number of metastatic sites.
Maltese: Āiet osservata korrelazzjoni poŜittiva bejn it-teħid skeletriku u lgħadd ta' siti metastatiëi.
English: Stomach
Maltese: Pulmun
English: The primary radiation emissions of samarium-153 are shown in Table 1.
Maltese: L-emissjonijiet tar-radjazzjoni primarja ta' samarium153 qed jiāu elenkati fit-Tabella 1.
English: GLASS VIAL
Maltese: GĦALL-ĦRUĀ
English: In clinical trials white blood cell and platelet counts decreased to a nadir of approximately 40 % to 50 % of baseline 3 to 5 weeks after a dose, and generally returned to pre-treatment levels by 8 weeks post treatment.
Maltese: Fi provi kliniëi, l-għadd ta' ëelluli bojod tad-demm u l-għadd ta' plejtlits naqas għal l-aktar punt baxx ta' madwar 40 % sa 50 % tal-linja ta' riferiment baŜi, 3 sa 5 āimgħat wara d-doŜa, u āeneralment reāa' lura għal-livelli ta' qabel il-kura sa 8 āimgħat wara.
English: Do not use Quadramet after the expiry date which is stated on the label.
Maltese: TuŜax Quadramet wara d-data ta' meta tiskadi li tidher fuq it-tikketta.
English: The few patients who experienced Grade 3 or 4 hematopoietic toxicity usually either had a history of recent external beam radiation therapy or chemotherapy or had rapidly progressive disease with probable bone marrow involvement.
Maltese: Il-ftit pazjenti li kellhom tossiëità ematopojetika ta' Grad 3 jew 4 normalment kienu ħadu jew terapija ta' radjazzjoni bir-raāāi esterni reëentement, jew kemjoterapija, jew kellhom marda progressiva ħafna bil-probabbilità tal-involviment tal-mudullun.
English: 5.1 Pharmacodynamic properties
Maltese: .1 Proprjetajiet farmakodinamiëi
English: Each ml of solution contains 1.3 GBq Samarium (153Sm) lexidronam pentasodium at the reference date
Maltese: Kull ml ta' soluzzjoni fih 1,3 GBq Samarium (153Sm) lexidronam pentasodium fid-data ta' riferiment
English: Each vial contains 1.5 ml (2 GBq at reference) to 3.1 ml (4 GBq at reference) of solution for injection.
Maltese: Kull kunjett fih 1.5 ml (riferiment ta' 2 GBq) sa 3.1 ml (riferiment ta' 4 GBq) ta' soluzzjoni għall-injezzjoni.
English: One single dose of 37 megabecquerel (Becquerel is the unit in which radioactivity is measured) of Quadramet per kilogram of body weight is to be injected.
Maltese: DoŜa waħda ta' 37 megabecquerel (Becquerel huwa l-unità li biha titkejjel ir-radjuattività) ta' Quadramet għal kull kilogramm tal-piŜ tal-āisem li għandu jiāi injettat.
English: 15 ml colourless European Pharmacopoeia Type I drawn glass vial closed with Teflon-coated chlorobutyl/natural rubber stopper and aluminium flip-off overseal.
Maltese: Kunjett tal-ħāieā ta' 15 ml ta' Tip I tal-Farmakopea Ewropea mingħajr kulur magħluq b'tapp talchlorobutyl miksi bit-Teflon/gomma naturali u b'siāill tal-aluminju li jinfetaħ b'daqqa ta' saba'.
English: Quadramet is contra-indicated (see 4.3) in pregnancy.
Maltese: Quadramet m'għandux jintuŜa fit-tqala (ara 4.3).
English: NAME OF THE MEDICINAL PRODUCT Quadramet 1.3 GBq/mL solution for injection.
Maltese: Quadramet 1.3 GBq/ml soluzzjoni għall-injezzjoni.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Quadramet 1.3 GBq/mL solution for injection Samarium (153Sm) lexidronam pentasodium
Maltese: U MNEJN GĦANDU JINGĦATA Quadramet 1.3 GBq/ml soluzzjoni għall-injezzjoni Samarium (153Sm) lexidronam pentasodium:
English: EXPIRY DATE
Maltese: DATA TA' REVIśJONI TAT-TEST
English: SPECIAL STORAGE CONDITIONS Store in a freezer at -10°C to -20°C in the original package Use within 6 hours of thawing
Maltese: AħŜen fil-friŜa ftemperatura ta' -10°C sa -20°C fil-pakkett oriāinali
English: Dosage
Maltese: DoŜaāā
English: Quadramet is a medicinal product for therapeutic use only.
Maltese: Quadramet huwa prodott mediëinali għal uŜu terapewtiku biss.
English: BATCH NUMBER Batch:
Maltese: NUMRU TAL-LOTT Lot:
English: This medicinal product is not intended to be injected on a regular or continuous basis.
Maltese: Dan il-prodott mediëinali mhuwiex intenzjonat li jiāi njettat fuq baŜi regolari u kontinwa.
English: The dosimetry estimates were based on clinical biodistribution studies using methods developed for radiation dose calculations by the Medical Internal Radiation Dose (MIRD) Committee of the Society of Nuclear Medicine.
Maltese: Dawn il-metodi ħarāu millKumitat tad-DoŜa ta' Radjazzjoni Interna Medika (MIRD) tas-Soëjetà tal-Mediëina Nukleari.
English: Name and address of the manufacturer responsible for batch release
Maltese: Isem u indirizz tal-manifattur responsabbli għall-ħruā tal-lott
English: 233 keV.
Maltese: Kull kunjett fih 2-4
English: Chest
Maltese: MHUX
English: • in patients having received chemotherapy or hemi-body external radiation therapy in a preceding period of 6 weeks.
Maltese: • Jekk irëevejt kimoterapija jew terapija ta' radjazzjoni esterna fuq nofs il-gisem matul perijodu preëedenti ta' 6 āimgħat.
English: You will be authorised to leave the nuclear medicine department after a dosimetric follow-up (generally within 6 hours following Quadramet injection).
Maltese: Inti tiāi awtoriŜŜat toħroā mid-dipartiment ta' mediëina nukleari wara li tiāi analizzat għad-doŜimetrija (āeneralment fi Ŝmien 6 sigħat wara l-injezzjoni ta' Quadramet).
English: 4.5 Interaction with other medicinal products and other forms of interaction
Maltese: Interazzjoni ma' prodotti mediëinali oħra u forom oħra ta' interazzjoni
English: This is usually mild and self-limiting and occurs within 72 hours of injection.
Maltese: Normalment, din tkun ħafifa u tgħaddi weħidha fi Ŝmien 72 siegħa millinjezzjoni.
English: Storage procedures should be in accordance with national regulations for radioactive materials.
Maltese: Il-proëeduri ta' ħaŜna għandhom ikunu konformi mar-regolamenti nazzjonali għal materjali radjuattivi.
English: The radiolysis products of Sm-EDTMP showed a renal toxicity in rats and dogs with a no effect level of 2.5 mg/kg.
Maltese: Il-prodotti ta' radjoliŜi ta' Sm-EDTMP urew tossiëità fil-kliewi tal-firien u tal-klieb, u b'livell ta' mingħajr effett ta' 2.5 mg/kg.
English: Because Quadramet is excreted in the urine, radiation exposure was based on a urinary voiding interval of 4.8 hours.
Maltese: Billi Quadramet jitneħħa fl-awrina, espoŜizzjoni għar-radjazzjoni kienet ibbaŜata fuq intervall taleliminazzjoni tal-awrina ta' 4.8 sigħat.
English: This medicinal product is a clear, colourless to light amber solution which is packed in a 15 ml colourless European Pharmacopoeia Type I drawn glass vial closed with Teflon-coated chlorobutyl/natural rubber stopper and aluminium flip-off overseal.
Maltese: Il-prodott mediëinali huwa soluzzjoni ëara, mingħajr kulur għal ambra ëara li tiāi ppakkjata f'kunjett mingħajr kulur tal-ħāieā miābud ta' Tip I tal-Farmakopea Ewropea b'għatu ta' chlorobutyl/lasktu naturali li għandu kisja tat-Teflon u tapp tal-aluminju li jista' jinqala' bis-suba'
English: A few patients experienced cord/root compressions, disseminated intravascular coagulation and cerebrovascular accidents.
Maltese: Xi ftit pazjenti ħassew tagħfis tal-kord/għerq, koagulazzjoni intravaskulari mxerrda u aëëidenti ëerebrovaskulari.
English: PHARMACOLOGIC PROPERTIES
Maltese: GĦAMLA FARMAêEWTIKA
English: The MAH must ensure that the system of pharmacovigilance presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the medicinal product is on the market.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jiŜgura li s-sistema ta' farmakoviāilanza ppreŜentata f'Modulu 1.8.1. tal-applikazzjoni għall-awtorizzazzjoni għat-tqegħid fis-suq tkun fis-seħħ u tiffunzjona qabel u waqt li l-prodott mediëinali jkun fuq is-suq.
English: Use within 6 hours of thawing.
Maltese: UŜa fi Ŝmien 6 sigħat wara li jinħall.
English: Organ
Maltese: LISTA
English: Such reactions are usually responsive to analgesics.
Maltese: Reazzjonijiet bħal dawn normalment jirrispondu tajjeb għall-analāesiëi.
English: INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
Maltese: GĦAR-RIMI TA' PRODOTTI MEDIêINALI
English: Pancreas
Maltese: DOśIMETRIJA
English: In absence of clinical data, the injected activity should be adapted to the renal function.
Maltese: Fin-nuqqas ta' tagħrif kliniku, l-attività injettata għandha tiāi adattata għal-funzjoni tal-kliewi.
English: PHARMACEUTICAL PARTICULARS
Maltese: PROPRJETAJIET FARMAKOLOĀIêI
English: The data on the safety of repeated dosing are limited and based on compassionate use of the product.
Maltese: L-informazzjoni dwar is-sigurtà ta' doŜi ripetuti hija limitata u hija bbaŜata fuq l-uŜu tal-prodott f'individwi.
English: Brain
Maltese: Il-marrara
English: Posology The recommended dose of Quadramet is 37 MBq per kg body weight.
Maltese: PoŜoloāija Id-doŜa rrakkomandata ta' QUADRAMET hija ta' 37 MBq għal kull kg tal-piŜ tal-āisem
English: For an administered activity of 2 590 MBq, the typical radiation dose to the target organ, skeletal metastases, is 86.5 Gy and the typical radiation doses to the critical organs are: normal bone surfaces 17.5 Gy, red marrow 4.0 Gy, urinary bladder wall 2.5 Gy, kidneys 0.047 Gy and ovaries 0.021 Gy.
Maltese: Quadramet huwa indikat għas-serħan mill-uāigħ fl-għadam, f'pazjenti b'metastasi skeletali ostejoblastika multipla bl-uāigħ, li tieħu biphosphonates immarkati b'sustanza radjuattiva ta' technetium (99mTc) għal skan tal-għadam.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING METALLIC BOX / LEADPOT
Maltese: Jekk tieħu Quadramet aktar milli suppost