FrancophonIA/ELRC3.0 huggingface dataset:
English: Immunological responses to the CDV, CAV and CPV components of the vaccine may be delayed due to maternally derived antibody interference.
Maltese: Ir-rispons immunoloġiku għall-komponenti CDV, CAV u CPV tal-vaċċin jistgħu jiġu ttardjati minħabba interferenza mal-antikorpi derivati mill-omm.
English: − to prevent mortality and clinical signs caused by canine adenovirus type 1,
Maltese: − biex tilqa' għal mortalità u sinjali kliniċi kkawżati mill-canine adenovirus tip 1,
English: However, the vaccine has been proven to be protective against virulent challenge in the presence of maternally derived antibodies to CDV, CAV and CPV at levels equal or higher to those likely to be encountered under field conditions.
Maltese: Mandankollu, ġie ppruvat li t-tilqima toffri protezzjoni fil-presenza ta' antikorpi derivati mill-omm kontra sfidi virali tal CDV, CAV u CPV f'livelli daqs jew ogħla minn dawk li x'aktarx jinstabu f'kundizzjonijiet reali.
English: Lyophilisate: spongy matter of white colour.
Maltese: Lijofiliżat: materja bħal sponża ta' lewn bajdani.
English: TCID50
Maltese: Dextran 70
English: Pack sizes:
Maltese: Solve nt:
English: The live attenuated virus vaccine strains CAV-2, CPiV and CPV-2b may be shed by vaccinated dogs following vaccination, shedding of CPV has been shown for up to 10 days.
Maltese: L-istrejn attenwati ħajjin mill-vaċċin tal-virus CAV-2, CPiV u CPV-2b jistgħu jinxterdu mill-klieb imlaqqma wara t-tilqima, tixrid ta' CPV deher sa 10 ijiem.
English: At least one year following the primary vaccination course for canine parainfluenza virus.
Maltese: Tal-anqas sena wara l-kors ta' tilqim primarju għall-canine parainfluenza virus.
English: If protection against Leptospira is required dogs can be vaccinated with two doses of Versican Plus DHPPi mixed with Versican Plus L4 3-4 weeks apart from 6 weeks of age: The contents of a single vial of Versican Plus DHPPi should be reconstituted with the contents of a single vial of Versican Plus L4 (instead of the solvent).
Maltese: Jekk hemm bżonn ta' protezzjoni kontra l-Leptospira, il-klieb jistgħu jitlaqqmu b'żewġ dożi ta' Versican Plus DHPPi imħallta ma' Versican Plus L4 3-4 ġimgħat minn xulxin minn età ta' 6 ġimgħat.
English: Pharmacotherapeutic group: Immunologicals for canidae, live viral vaccines.
Maltese: Immunoloġiċi għal canidae, vaċċini virali ħajjin.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus DHPPi lyophilisate and solvent for suspension for injection for dogs
Maltese: VETERINARJU Versican Plus DHPPi lijofiliżat u solvent għal sospensjoni għall-injezzjoni għall-klieb
English: Second dose: Versican Plus DHPPi mixed with Versiguard Rabies 3-4 weeks later, but not before 12 weeks of age.
Maltese: It-tieni doża: Versican Plus DHPPi mħalta ma' Versiguard Rabies 3-4 ġimgħat wara imma mhux qabel l-età ta' 12-il ġimgħa.
English: Shake well and administer immediately the entire contents (1 ml) of the reconstituted product.
Maltese: Ħallat sew u immedjatament amministra lkontenut kollu (1 ml) tal-prodott rikostitwit.
English: The vaccine virus strain CPV-2b has not been tested in other carnivores (except dogs and domestic cats) that are known to be susceptible to canine parvoviruses and therefore vaccinated dogs should be separated from them after vaccination.
Maltese: L-istrejn tal-virus CPV-2b tal-vaċċin ma ġiex ittestjat fuq karnivori oħra (ħlief klieb u qtates domestiċi) li hu magħruf li huma suxxettibbli għall-canine parvoviruses u għalhekk klieb imlaqqma għandhom jiġu sseparati minnhom wara t-tilqima.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous use.
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI Użu taħt il-ġilda.
English: PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection
Maltese: GĦAMLA FARMAĊEWTIKA Lijofiliżat u solvent għal sospensjoni għall-injezzjoni.
English: − to prevent clinical signs (nasal and ocular discharge) and reduce viral excretion caused by canine parainfluenza virus.
Maltese: − biex tilqa' għas-sinjali kliniċi (tnixxija mill-imnieħer u l-għajnejn) u tnaqqas it-tixrid virali kkawżat mill-canine parainfluenza virus.
English: Keep out of the sight and reach of children.
Maltese: L-anoressija u nuqqas fl-attività rari ġew osservati.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 1 ml contains:
Maltese: Kull doża (1 ml) fiha:
English: Immunocompetence of the animal may be compromised by a variety of factors including poor health, nutritional status, genetic factors, concurrent drug therapy and stress.
Maltese: Ilkompetenza immunitarja tal-annimal tista' tiġi kompromessa minn varjetà ta' fatturi li jinkludu saħħa fqira, stat nutrizzjonali, fatturi ġenetiċi, kura b'mediċini fl-istess ħin u stress.
English: B. PACKAGE LEAFLET
Maltese: DAQS TAL-PAKKETT
English: Type I glass vial containing 1 dose of lyophilisate closed with a bromobutyl rubber stopper and aluminium cap.
Maltese: Kunjett tal-ħġieġ Tip I li fih doża waħda ta' lijofiliżat magħluq b'tapp tal-bromobutyl rubber u kappa tal-aluminju.
English: 103.6 TCID50
Maltese: 4.11 Perjodu ta' tiżmim
English: Systemic reactions such as lethargy, hyperthermia and general malaise may occur very rarely.
Maltese: Reazzjonijidet sistemiċi bħal letarġija, ipertermja u telqa' ġenerali rari ħafna jseħħu.
English: The contents of a single vial of Versican Plus DHPPi should be reconstituted with the contents of a single vial of Versiguard Rabies (instead of the solvent).
Maltese: Il-kontenut ta' kunjett wieħed ta' Versican Plus DHPPi għandu jiġi rikostitwit mal-kontenut ta' kunjett wieħed ta' Versiguard Rabies (minnflok is-solvent).
English: − to prevent clinical signs and reduce viral excretion caused by canine adenovirus type 2,
Maltese: − biex tilqa' għas-sinjali kliniċi u tixrid virali kkawżat mill-canine adenovirus tip 2,
English: Manufacturer responsible for batch release:
Maltese: Skema għat-tilqima ripetuta:
English: EXPIRY DATE
Maltese: ANNESS I
English: Although the efficacy of the rabies fraction has been demonstrated following administration at 12 weeks, at the discretion of the veterinary surgeon, in case of need, dogs younger than 8 weeks can be vaccinated with Versican Plus DHPPi mixed with Versiguard Rabies as the safety of this association has been demonstrated in 6 week old dogs.
Maltese: Għalkemm l-effikaċja tal-frazzjoni tar-rabbja ġiet murija wara amministrazzjoni fit-12-il ġimgħa, fiddiskrezzjoni tal-veterinarju, f'każ ta' bżonn, klieb ta' anqas minn 8 ġimgħat jistgħu jiġu mlaqqma b'Versican Plus DHPPi mħallat ma' Versiguard Rabies billi s-sigurtà ta' din l-assoċjazzjoni ġiet stabbilita fi klieb ta' 6 ġimgħat.
English: Dogs.
Maltese: Klieb.
English: Interaction with other medicinal products and other forms of interaction: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product other than Versiguard Rabies and Versican Plus L4.
Maltese: M'hemmx informazzjoni dwar is-sigurtà u l-effikaċja ta' dan il-vaċċin jekk jintuża flimkien ma' kwalunkwe prodott mediċinali veterinarju ieħor ħlief Versiguard Rabies u Versican Plus L4.
English: Primary vaccination scheme: Two doses of Versican Plus DHPPi 3-4 weeks apart from 6 weeks of age.
Maltese: Żewġ dożi ta' Versican Plus DHPPi 3-4 ġimgħat minn xulxin minn età ta' 6 ġimgħat.
English: PACKAGE LEAFLET: Versican Plus DHPPi lyophilisate and solvent for suspension for injection for dogs
Maltese: Versican Plus DHPPi lijofiliżat u solvent għal sospensjoni għall-injezzjoni għall-klieb
English: In case of travelling to risk areas or outside the EU, veterinary surgeons may wish to give additional rabies vaccinations after 12 weeks of age to ensure that the vaccinated dogs have an antibody titre of ≥ 0.5 IU/ml, which is generally regarded as sufficiently protective and that they meet the travel test requirements (antibody titres ≥ 0.5 IU/ml).
Maltese: F'każ ta' vjaġġar lejn żoni ta' riskju jew barra mill-UE, veterinarji jistgħu jagħżlu li jagħtu aktar tilqimiet tar-rabbja wara letà ta' 12-il ġimgħa biex ikun żgurat li l-klieb imlaqqma ikollhom livelli ta' antikorpi ≥ 0.5
English: 103.6 TCID50* 105.3 TCID50
Maltese: Xi annimali jistgħu wkoll ma jurux livelli > 0.5
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus DHPPi lyophilisate for dogs
Maltese: Tużax dan il-prodott mediċinali veterinarju wara d-data ta' skadenza murija fuq it-tikketta wara JISKADI.
English: MA (EU) Number (Invented) name
Maltese: Numru tal-MA (EU)
English: Immediate Packaging Pack size
Maltese: Il-pakkett li jmiss malprodott
English: Strength
Maltese: Daqs talpakkett
English: Percent 99mTc-depreotide: 100 - (A + B).
Maltese: Persentaġġ ta' 99mTc-depreotide: 100 - (A + B).
English: See section 4.4
Maltese: Ara taqsima 4.4
English: 1) Saturated sodium chloride solution (SSCS)
Maltese: 1) Soluzzjoni saturata ta' sodium chloride (SSCS)
English: 91192 GIF sur YVETTE cedex FRANCE
Maltese: 91192 GIF sur YVETTE cedex FRANZA
English: NeoSpect 47 micrograms.
Maltese: NeoSpect 47 mikrogramma.
English: below) 1:1 (v/v) methanol / 1M ammonium acetate (MAM)2 (2 See section 2.)
Maltese: 1:1 (v/v) methanol / 1M ammonium acetate (MAM)2 (2 Ara taqsima 2.) hawn isfel)
English: below.
Maltese: MBq.
English: See Cautionary notes 1 and 2
Maltese: Ara n-noti ta' kawtela 1 u 2
English: All were uncommon (0.1%-1%) in occurrence.
Maltese: Ma kienux komuni (0.1% - 1%).
English: Observed changes in the laboratory parameters are: increased WBC count, basophils, eosinophils, monocytes and neutrophils, AST, ALT, LDH, total bilirubin and total protein; lowered RBC count and
Maltese: Il-bidliet fil-parametri tal-laboratorju li ġew osservati huma: livelli ogħla fl-għadd tal-WBC, talbażofili, tal-eżinofili, tal-monoċiti u tan-newtrofili, ta' l-AST, l-ALT, l-LDH, tal-bilirubin totali u talproteini totali; livelli mnaqqsa fl-għadd tar-RBC u tal-proteinI totali.
English: The effective dose (ED) calculated in accordance with ICRP Publication 60 (Pergamon Press, 1991) gave a value of 0.016 mSv/MBq, corresponding to 11.84 mSv after
Maltese: Id-doża effettiva (ED) kkalkulata skond il-pubblikazzjoni ICRP 60 (Pergamon Press, 1991) tat valur ta' 0.016 mSv/MBq, li jikkorrospondi għal 11.84 mSv wara li jingħata 740
English: 1:1 Methanol / 1M Ammonium Acetate (MAM) - Carefully mix one part methanol with one part 1M Ammonium Acetate.
Maltese: 1:1 Methanol / 1M Ammonium Acetate (MAM) - Ħallat b'attenzjonji parti waħda tal-methanol ma' parti waħda ta' 1M Ammonium Acetate.
English: The negative predictive value was 87.5% (CI 66.5-96.7%) for all lesions and 87.5% for lesions equal to or less than 3cm.
Maltese: Il-valur negattiv imbassar kien ta' 87.5% (Cl 66.596.7%) għall-feriti kollha u 87.5% għall-feriti ta' 3 ċm jew inqas.
English: Studies in healthy volunteers have demonstrated that the tracer confers three-compartment pharmacokinetic characteristics with a distribution half-life of less than 5 minutes and a terminal halflife of about 20 hours, and a steady-state volume of distribution of 1.5 to 3 l/kg.
Maltese: Studji f'volontarji f'saħħithom urew li t-tracer jagħti karatteristiċi farmakokinetiċi fit-tliet kompartimenti b'half life ta' 5 minuti u b'half life terminali ta' 20 siegħa, u volum ta' distribuzzjoni stabbli ta' bejn 1.5 u 3 l/kg.
English: ITLC-SG SSCS: cut the strip at Rf 0.75 (75% of the distance from the origin to the solvent
Maltese: ITLC-SG SSCS: aqta' l-istrixxa f'Rf 0.75 (75% tad-distanza mill-oriġini sal-front tas-solvent).
English: Two Gelman ITLC-SG strips (2 cm x 10 cm) Two developing tanks and covers
Maltese: Żewġ strixxi Gelman ITLC-SG (2 ċm x 10 ċm) 2.
English: ITLC-SG MAM: cut the strip at Rf 0.40 (40% of the distance from the origin to the solvent
Maltese: ITLC-SG MAM: aqta' l-istrixxa f'RF 0.40 (40% tad-distanza mill-oriġini sal-front tas-solvent).
English: For a full list of excipients, see section 6.1
Maltese: Għal-lista kompleta ta' sustanzi mhux attivi, ara sezzjoni 6.1.
English: In view of the false negative rate of FNA (5-8% false negative rate reported), thoracotomy is considered to be the gold standard.
Maltese: Minħabba ir-rata negattiva falza ta' l-FNA (ġiet rappurtata rata negattiva falza ta' bejn 5 u 8%), it-torakotomija titqies il-metodu li miegħu iridu jitqabblu l-oħrajn kollha.
English: Stannous chloride dihydrate 50 micrograms (essential excipient)
Maltese: Stannous chloride dihydrate 50 mikrogrammi (ingredjent mhux attiv essenzjali) sodium α
English: Radioactivity in top piece of ITLC-SG SSCS strip (Rf 0.75-1.0) B = 100 x -----------------------------------------------------------------------------Total radioactivity in both pieces of ITLC-SG SSCS Strip
Maltese: Radjuattivita` fil-biċċa ta' fuq ta' l-istrixxa ITLC-SG SSCS (Rf 0.75-1.0) B = 100
English: - The other ingredients are sodium glucoheptonate dihydrate, stannous chloride dihydrate,
Maltese: • L-ingredjenti l-oħra huma sodium glucoheptonate dihydrate, stannous chloride dihydrate,
English: Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/
Maltese: Informazzjoni dettaljata dwar dan il-prodott tinsab fuq il-website ta' l-Aġenzija Ewropeja dwar ilmediċini (EMEA) http://www.emea.europa.eu/.
English: * abdominal pain
Maltese: * uġigħ addominali
English: Instructions for the preparation of 99mTc-depreotide:
Maltese: Istruzzjonijiet kif tipprepara 99mTc-depreotide:
English: Plasma radioactivity is predominantly (>90%) in parent form, i.e. as 99mTc-depreotide.
Maltese: Ir-radjuattivita` tal-plażma kienet l-iktar (>90%) fil-forma oriġinali, i.e. bħala 99mTc-depreotide.
English: Percent technetium (99mTc) pertechnetate, technetium-99m labelled glucoheptonate and
Maltese: Persentaġġ tat- technetium (99mTc) pertechnetate, glucoheptonate tikkettat b'technetium-99m u edetate tikkettat b'technetium-99m = B
English: Total clearance averaged 2 to 4 ml/min/kg.
Maltese: Ir-rata tat-tneħħija kienet ta' bejn 2 u 4 ml/min/kg.
English: Percent technetium-99m non-mobile material = A
Maltese: Persentaġġ ta' materjal mhux mobbli ta' technetium-99m = A
English: Kit for radiopharmaceutical preparation Depreotide
Maltese: Sett għall-preparazzjoni radjufarmaċewtika Depreotide
English: In a recent clinical study with a prevalence of malignancy of 49%, the positive predictive value for NeoSpect in association with CT/chest X-ray was 84% (CI 63.1-94.7%) for all SPNs and 81.8% for lesions equal to or less than 3cm.
Maltese: Fi studju kliniku li sar reċenti fejn it-tumur malinn kien preżenti f'49% mill-każi, il-valur pożittiv imbassar għan-NeoSpect meta ntuża ma' CT/raġġi X tas-sider kien ta' 84% (CI 63.1-94.7%) għal kull SPN u 81.8% għal feriti ta' 3 ċm jew inqas.
English: There is only limited data available regarding interactions with other products.
Maltese: Hemm biss tagħrif limitat dwar l-interazzjonijiet ma' prodotti oħra.
English: After reconstitution, store at 15 °C - 25 °C and use within 5 hours.
Maltese: Wara r-rikostituzzjoni, aħżen f'temperatura ta' bejn 15°C - 25°C u użah wara 5 sigħat.
English: Name and address of the manufacturer responsible for batch release CIS bio international
Maltese: Isem u indirizz tal-manifattur(i) responsabbli għall-hruġ tal-lott CIS bio international
English: Dose calculations were performed using the standard MIRD method (MIRD Pamphlet No. 1 rev., Soc. Nucl.
Maltese: Il-kalkulazzjonijiet tad-dożi saru skond il-metodu standard MIRD (Fuljett ta' l-MIRD Nru 1 rev., Soc.
English: Continue until a solid residue remains.
Maltese: Kompli sakemm jibqa' xi fdal solidu.
English: Each vial contains: 47 micrograms depreotide as depreotide trifluoroacetate
Maltese: Kull fjala fiha: 47 mikrogramma depreotide bħala depreotide trifluoroacetate
English: Sticker label to be applied after reconstitution:
Maltese: Id-detentur ta' l-awtorizzazzjoni għat-tqegħid fis-suq u l-Manifattur:
English: Technetium-99m disintegrates by isomeric transition with the emission of gamma radiation with an energy of 140 keV and a half life of 6 hours to technetium-99, which can be regarded as quasi stable.
Maltese: Technetium-99m jiddiżintegra bi tranżizzjoni iżomerika bil-ħruġ tar-radjazzjoni gamma b'enerġija ta' 140keV u b'half life ta 6 sigħat.
English: The scanning may take place 2-4 hours after injection of NeoSpect.
Maltese: L-iskan jista' jittieħed minn 2-4 sigħat wara l-injezzjoni ta' NeoSpect.
English: 99mTc-depreotide is therefore contraindicated in pregnancy.
Maltese: Għalhekk 99mTc-depreotide huwa kontra-indikat fit-tqala.
English: * dizziness
Maltese: * dijarrea
English: 5 vials, each vial containing 47 micrograms of depreotide.
Maltese: 5 kunjetti, kull kunjett fih 47 mikrogramma ta' depreotide.
English: - The active substance is 47 micrograms depreotide as depreotide trifluoroacetate.
Maltese: • Is-Sustanza attiva hija 47 mikrogramma ra' depreotide bħala depreotide trifluoroacetate.
English: 99mTc-depreotide binds to the extent of about 12% to plasma proteins in patients and healthy
Maltese: 99mTc-depreotide jintrabat sa 12% mal-proteini tal-plażma kemm f'pazjenti kif ukoll f'voluntiera
English: 1 vial containing 47 micrograms of depreotide.
Maltese: Kunjett 1 fih 47 mikrogramma ta' depreotide.
English: Spot one drop (approximately 5-10 microlitres) of 99mTc-depreotide at the origin of each strip using the hypodermic needle.
Maltese: 3. B'labra ipodermika qattar taqtira waħda (bejn wieħed u ieħor 5-10 mikrolitri) ta' 99mTc-depreotide fil-bidu ta' kull strixxa.
English: Add distilled water up to the 50 ml mark, mix thoroughly.
Maltese: Żid ilma distillat sal-marka tal-50 ml, u ħallat sew.
English: Equipment and Materials
Maltese: Tagħmir u Materjali
English: NeoSpect is used for preparation of technetium (99mTc) depreotide solution for injection.
Maltese: NeoSpect jintuża għall-preparazzjoni ta' technetium (99mTc) depreotide soluzzjoni għall-injezzjoni.
English: May be prepared by adding about five grams of sodium chloride to the bottom of one chromatography chamber; add approximately 10 millilitres of distilled water to the solid sodium chloride and shake periodically during 10 to 15 minutes.
Maltese: Jista' jiġi ppreparat billi żżid ħames grammi ta' sodium chloride fil-qiegħ ta' kaxxa talkromatografija; żid bejn wieħed u ieħor 10 millilitri ta' ilma distillat mas-sodium chloride solidu u ħawwad perjodikament għal bejn 10 u 15-il minuta.
English: Radioactivity in bottom piece of ITLC-SG MAM strip (Rf 0-0.40) A = 100 x ---------------------------------------------------------------------------------Total radioactivity in both pieces of ITLC-SG MAM strip
Maltese: Radjuattivita` fil-biċċa t'isfel ta' l-istrixxa ITLC-SG MAM (Rf 0-0.40) A = 100 x ---------------------------------------------------------------------Radjuattivita` totali fiż-żewġ biċċiet ta' l-istrixxa ITLC-SG MAM
English: The binding affinity of 99mTc-depreotide to SSTR was shown in studies of pancreatic tumours in Lewis rats and in vitro in human tumour membranes.
Maltese: It-tendenza tad-99mTc-depreotide li jintrabat ma' l-SSTR intweriet fi studji fuq tumuri tal-firxa f'firien Lewis u in vitro f'membrani tat-tumur fil-bniedem.
English: For this product, the effective dose resulting from an administered activity of 555-740 MBq is typically 8.88-11.84 mSv for a 70 kg individual.
Maltese: MBq tipikament hija ta' 8.88-11.84 mSv għal individwu li jiżen 70 kg.
English: The vial contains no bacteriostatic preservative.
Maltese: Il-fjala ma fihiex preservattivi batterjostatiċi.
English: Renal clearance averaged about 0.3 ml/min/kg.
Maltese: Ir-rata tat-tneħħija millkliewi kienet ta' madwar 0.3 ml/min/kg.
English: 2) 1:1 Methanol / 1M Ammonium Acetate (MAM) 1M Ammonium Acetate - Add 3.9 ± 0.1 grams of solid ammonium acetate to a 50 ml volumetric flask.
Maltese: Żid iktar ilma distillat jew sodium chloride skond il-bżonn meta se jintuża drabi oħra basta dejjem ikun hemm xi fdal mhux imdewweb tas-sodium2) 1:1 Metanol / 1M Acetat ta' l-Ammonju (MAM) 1M Ammonium Acetate- Żid 3.9 ± 0.1 grammi ta' ammonium acetate solidu fi flixkun volumetriku ta' 50 ml.
English: 99mTc-depreotide is indicated for single use only.
Maltese: 99mTc-depreotide huwa indikat għal użu ta' darba.
English: A separate cannula should be used.
Maltese: Għandha tintuża kannula separata.
English: Lactation
Maltese: DOŻIMETRIJA
English: disodium edetate and hydrochloric acid and/or sodium hydroxide to adjust pH.
Maltese: Disodium edetate Hydrochloric acid u/jew sodium hydroxide (biex jistabbilizza l-pH)
English: NeoSpect is supplied in packs of 1 vial and 5 vials, each vial containing 47 micrograms depreotide.
Maltese: NeoSpect jiġi f'pakketti ta' fjala waħda jew 5 fjali, kull fjala jkun fiha 47 mikrogrammi ta' depreotide.
English: In vitro data and studies in laboratory animals indicate that 99mTc-depreotide binds with high affinity to somatostatin receptor (SSTR) subtypes 2, 3
Maltese: Tagħrif in vitro u studji fuq l-annimali fil-laboratorju jindikaw li 99mTc-depreotide jintrabat b'affinita' qawwija massottotipi 2, 3 u 5 tar-riċettur ta' somatostatin (SSTR).
English: Kidneys Spleen
Maltese: Ż-ŻGĦAR EWLENIN
English: The values are listed in descending order as mGy/MBq and assume urinary bladder emptying at 4.8 hours.
Maltese: Il-valuri qegħdin f'ordni mill-ikbar sa l-iżgħar bħala mGy/MBq u jassumu li l-borża ta' l-urina titbattal wara 4.8 sigħat.
English: 99mTc-depreotide was not mutagenic in vitro in the Ames test or mouse lymphoma test, and it was not clastogenic in vivo in the mouse micronucleus test.
Maltese: 5.3 Tagħrif ta' qabel l-użu kliniku dwar is-sigurtà tal-mediċina 99mTc-depreotide in vitro ma kienx mutaġeniku fit-test ta' Ames jew fit-test tal-limfoma fil-ġrieden, u in vivo u ma kienx klastoġeniku fit-test tal-mikronukleju fil-ġrieden.
English: One to 18% of the injected dose of radioactivity appeared in the urine at 4 hours after injection.
Maltese: Minn 1 sa 18% tad-doża tar-radjuattivita` li kienet injettata dehret fl-urina 4 sigħat wara l-injezzjoni.
English: The recommended dosage is one vial (approximately 47 micrograms of depreotide) labelled with
Maltese: Id-doża rakkomandata hija fjala waħda (bejn wieħed u ieħor 47 mikrogramma ta' depreotide) tikkettati
English: Sodium chloride 0.9% w/v solution for injection must be used as the diluent.
Maltese: Is-soluzzjoni għall-injezzjoni ta' 0.9% w/v sodium chloride trid tintużaw bħala dilwent.
English: The MAM should be prepared fresh daily.
Maltese: Il-MAM għandu jiġi ppreparat frisk kuljum.
English: Due to the short, six-hour half-life of technetium-99m, less than 0.1% of the radioactivity remains
Maltese: Minħabba li l-half life ta' t-technetium-99m hija qasira - 6 sigħat, tibqa' inqas minn 0.1% tarradjuattivita` 60 siegħa wara li tkun ingħatat.
English: A value of at least 90% should be obtained in a satisfactory preparation.
Maltese: Fi preparazzjoni sodisfaċenti jrid ikun hemm valur ta' mill-inqas 90%.
English: After reconstitution with sodium pertechnetate (99mTc) solution for injection, 99mTc-depreotide is
Maltese: Meta soluzzjoni tas-sustanza radjuattiva, sodium pertechnetate (99mTc) tiżdied fil-fjala, jiġi ffurmat 99mTc-depreotide.
English: In the pivotal studies, the negative predictive value for NeoSpect in association with CT for solitary pulmonary nodules (SPNs) was 90-96% at a disease prevalence of 30-50%.
Maltese: Fl-istudji fundamentali, il-valur negattiv imbassar tan-NeoScan meta ntuża ma' CT għal għoqod tattumur waħidhom fil-pulmun (SPNs) kien ta' bejn id-90 u s-96% bi prevalenza tal-marda ta' bejn it-30 u l-50%.
English: * flushing
Maltese: * sturdament
English: Cap the
Maltese: L-KITBA
English: Reconstitute with sodium pertechnetate (99mTc) injection
Maltese: Kull ossidant preżenti fis-sodium pertechnetate (99mTc)
English: History of hypersensitivity reaction to depreotide, any of the excipients of NeoSpect or sodium pertechnetate (99mTc) solution for injection.
Maltese: Sensittività eċċessiva għas depreotide, xi sustanzi mhux attivi ta' NeoSpect jew għal sodium pertechnetate (99mTc) soluzzjoni għall-injezzjoni.
English: Testes
Maltese: EFFETTI
English: * fatigue
Maltese: * remettar
English: Saturated sodium chloride solution (SSCS)1 (1 See section 1.)
Maltese: Żewġ tankijiet u għotjien għall-iżvilupp 3. Soluzzjoni saturata ta' sodium chloride (SSCS)1 (1 Ara taqsima 1.) hawn isfel) 4.