FrancophonIA/ELRC3.0 huggingface dataset:
English: Proteinuria, increased blood creatinine
Maltese: EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: Isolated cases of haemolysis-related renal dysfunction/renal failure or disseminated intravascular coagulation and death have occurred.
Maltese: Irriżultaw każijiet iżolati ta' disfunzjoni renali/insuffiċjenza renali jew koagulazzjoni intravaskulari disseminata u mewt marbuta mal-emolisi.
English: 0.2 - 0.4 g/kg bw every 3 to 4 weeks
Maltese: 0.2 - 0.4 g/kg piż tal-ġisem kull 3 sa 4 ġimgħat
English: Rarely, human normal immunoglobulin can induce a fall in blood pressure with anaphylactoid reaction, even in patients who had tolerated previous treatment with human normal immunoglobulin.
Maltese: B'mod rari, l-immunoglobulina normali umana tista' tikkaġuna tnaqqis fil-pressjoni tad-demm b'reazzjoni anafilattojda, anki f'pazjenti li fil-passat ittolleraw kura b'imminoglobulina normali umana.
English: Pain (including back pain, pain in extremity, arthralgia, neck pain, facial pain) pyrexia (including chills), influenza like illness (including nasopharyngitis, pharyngolaryngeal pain, oropharyngeal blistering, throat tightness)
Maltese: Uġigħ (inkluż uġigħ fid-dahar, uġigħ fid-dirgħajn u fir-riġlejn, artralġja, uġigħ fl-għonq, uġigħ fil wiċċ) deni (inkluż tkexkix ta' bard), marda tixbah l-influwenza (inkluż nasofarinġite, uġigħ filfarinġi u fil-larinġi, infafet fil-ħalq u fil-farinġi, tagħfis fil-gerżuma)
English: Possible side effects may be reduced or even avoided by infusing Privigen at a slow infusion rate.
Maltese: Effetti sekondarji possibbli jistgħu jitnaqqsu jew anki jkunu evitati jekk l-infużjoni ta' Privigen tingħata b'rata baxxa.
English: Very Common (may occur with more than 1 in 10 patients):
Maltese: Komuni Ħafna (jistgħu jseħħu f'aktar minn pazjent 1 minn kull 10):
English: 19 children (3 to 11 years), 12 adolescents (12 to 16 years) and 49 adults were treated with Privigen over 12 months.
Maltese: L-istudju pivitali kritiku PID kien jinkludi total ta' 80 pazjent b'età bejn 3 snin u 69 sena. 19-il tifel u tifla (3 snin sa 11-il sena), 12 adolexxenti (12 sa 16-il sena) u 49 adult kienu kkurati bi Privigen fuq perijodu ta' 12-il xahar.
English: Temporary non-infectious meningitis (reversible aseptic meningitis), irregularity of red blood cell shape (microscopic finding), presence of high platelet counts in the blood (thrombocytosis), sleepiness, shiver (tremor), palpitations, tachycardia, thromboembolic events, lack of blood supply to the lower extremities causing e.g. pain when walking (peripheral vascular disorder), presence of an excess of serum proteins in the urine (proteinuria including increased blood creatinine), injection site pain
Maltese: Meninġite temporanja mhux infettiva (meninġite asettika riversibbli), irregolarità fil-forma taċ-ċelluli ħomor tad-demm (sejba mikroskopika), preżenza ta' għadd għoli ta' plejtilts fid-demm (tromboċitożi), ngħas, tkexkix (rogħda), palpitazzjonijiet, takikardija, avvenimenti tromboemboliċi, nuqqas ta'
English: Cases of acute renal failure have been reported in patients receiving IVIg therapy.
Maltese: Każijiet ta' insuffiċjenza akuta tal-kliewi ġew irrappurtati f'pazjenti li jkunu qed jirċievu terapija b'IVIg.
English: Privigen 100 mg/ml solution for infusion Human normal immunoglobulin (IVIg)
Maltese: Kull kunjett ta' 100 ml soluzzjoni fih: 10 g ta' immunoglobulina normali umana
English: Immunomodulation in adults, and children and adolescents (0-18 years) in: - Primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count.
Maltese: Privigen jintuża għall-kura tal-adulti u t-tfal (0 sa 18-il sena) fis-sitwazzjonijiet li ġejjin: A) biex iżid il-livelli baxxi b'mod anormali ta' immunoglobulina fid-demm tiegħek għal livelli normali (terapija ta' sostituzzjoni):
English: Solution for infusion.
Maltese: Soluzzjoni għall-infużjoni.
English: • formation of blood clots which may be carried off in the blood circulation (thromboembolic reactions) and which may result e.g. in myocardial infarction (e.g. when you have sudden chest pain or shortness of breath), stroke (e.g. when you have a sudden onset of muscle weakness, have loss of sensation and/or balance, decreased alertness or difficulty in speaking), blood clots in the arteries of the lungs (e.g. when you have chest pain, difficulty in breathing or are coughing up blood), deep vein thrombosis (e.g. when you have redness, feel warmth, pain, tenderness, or have a swelling of one or both legs),
Maltese: • formazzjoni ta' emboli tad-demm li jistgħu jinġarru fiċ-ċirkolazzjoni tad-demm (reazzjonijiet tromboemboliċi), u li jistgħu jirriżultaw f'eż. infart mijokardjali (eż. meta tħoss uġigħ f'daqqa f'sidrek jew qtugħ ta' nifs),puplesija (eż. meta jkollok bidu għal għarrieda ta' dgħufija fil muskoli, ikollok telf ta' sensazzjoni u/jew tal-bilanċ, tnaqqis f'kemm tkun attent jew diffikultà biex titkellem), emboli tad-demm fl-arterji tal-pulmun (eż. meta jkollok uġigħ fis-sider, diffikultà biex tieħu n-nifs jew bili bid-demm), trombożi tal-vini li ma jidhrux (eż. meta jkollok ħmura, tħoss is-sħana, uġigħ, sensittività, jew ikollok nefħa f'riġel wieħed jew f'riġlejk it-tnejn).
English: Adverse reactions such as chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, arthralgia, low blood pressure and moderate low back pain may occur occasionally in connection with intravenous administration of human immunoglobulin including Privigen.
Maltese: Reazzjonijiet avversi bħal tkexkix ta' bard, uġigħ ta' ras, sturdament, deni, rimettar, reazzjonijiet allerġiċi, dardir, artralġja, pressjoni tad-demm baxxa u uġigħ moderat fin-naħa t'isfel tad-dahar, jistgħu jseħħu kultant b'rabta mal-għoti mill-vini ta' immunoglobulina umana inkluż bi Privigen.
English: Please refer to section 4.4 for details on risk factors and monitoring recommendations.
Maltese: Jekk jogħġbok irreferi għal sezzjoni 4.4 għal dettalji fuq fatturi ta' riskju u rakkomandazzjonijiet dwar il-monitoraġġ.
English: Guillain-Barré syndrome 0.4 g/kg bw/day over 5 days.
Maltese: 0.4 g/kg piż tal-ġisem/kuljum fuq 5 ijiem.
English: The INCAT responder rate was 60.7% (95% confidence interval [42.41, 76.4]).
Maltese: Ir-rata ta' dawk li rrispondew għall-kura INCAT kienet 60.7% (intervall ta' kunfidenza ta' 95% [42.41, 76.4]). 9 pazjenti rrispondew wara li rċivew id-doża ta' induzzjoni inizjali sa ġimgħa 4, 16-il pazjent kellhom rispons sal-ġimgħa 10.
English: Adverse Drug Reaction
Maltese: TAL-PRODOTT MEDIĊINALI
English: Fertility
Maltese: FARMAĊEWTIKU
English: If well tolerated, the rate of administration may gradually be increased to a maximum of 4.8 ml/kg bw/hr.
Maltese: Jekk tkun ittollerata tajjeb, irrata tista' tiżdied gradwalment sa massimu ta' 4.8 ml/kg piż tal-ġisem/siegħa.
English: 25 patients (aged 13-69 years) participated in the pharmacokinetic (PK) assessment.
Maltese: Studju kliniku addizzjonali twettaq fi 13-il pazjent bil-PID (li kellhom minn 3-65 sena).
English: It has a distribution of immunoglobulin G subclasses closely proportional to that in native human plasma.
Maltese: Għandha distribuzzjoni ta' sottoklassijiet ta' immunoglobulina G li tixbah proporzjonalment mill-qrib lil dik li tinsab normalment fil-plażma umana.
English: Solution for infusion (10%) Contains 1 vial.
Maltese: U KONTENUT Soluzzjoni għall-infużjoni (10%)
English: Overdose is very unlikely to occur because Privigen is usually administered under medical supervision.
Maltese: Għalhekk, hemm possibbiltà remota ħafna li doża eċċessiva tista' sseħħ għax Privigen normalment jingħata taħt superviżjoni medika.
English: CSL Behring AB Sími: +46 8 544 966 70
Maltese: Tlf: +46 8 544 966 70
English: 10 g/100 ml
Maltese: EU/1/08/446/002 10 g/100 ml
English: 2.5 g/25 ml
Maltese: 2.5 g/25 ml 5 g/50 ml 10 g/100 ml 20 g/200 ml 40 g/400 ml
English: 50 or 100 ml of solution in a single vial (type I or II glass), with a stopper (elastomeric), a cap (aluminium crimp), a flip off disc (plastic), label with integrated hanger.
Maltese: 50 jew 100 ml ta' soluzzjoni f'kunjett wieħed (ħġieġ ta' tip I jew II), b'tapp (elastomeric), għatu
English: Starting dose: 2 g/kg given over 2-5 consecutive days.
Maltese: 2 g/kg mogħtija fuq 2-5 ijiem konsekuttivi.
English: Skin and subcutaneous tissue disorders
Maltese: Kontenut tas-sodium
English: Each vial of 25 ml solution contains: 2.5 g human normal immunoglobulin Each vial of 50 ml solution contains: 5 g human normal immunoglobulin Each vial of 100 ml solution contains: 10 g human normal immunoglobulin Each vial of 200 ml solution contains: 20 g human normal immunoglobulin Each vial of 400 ml solution contains: 40 g human normal immunoglobulin
Maltese: Kull kunjett ta' 25 ml soluzzjoni fih: 2.5 g ta' immunoglobulina normali umana
English: The product should be brought to room temperature (25°C) before use.
Maltese: Taħżinx f'temperatura 'l fuq minn 25 °C.
English: In Privigen clinical studies with paediatric patients, the frequency, nature and severity of adverse reactions did not differ between children and adults.
Maltese: Fi studji kliniċi dwar Privigen b'pazjenti pedjatriċi, il-frekwenza, in-natura u s-severità tarreazzjonijiet avversi ma kienux differenti bejn tfal u adulti.
English: CSL Behring NV Tél/Tel: +32 15 28 89 20
Maltese: CSL Behring Sp. z o.o. Tel: +48 22 213 22 65
English: This medicine contains trace amounts of IgA (not more than 25 micrograms/ml).
Maltese: Din il-mediċina fiha traċċi ta' ammonti ta' IgA (mhux aktar minn 25 mikrogramma/ml).
English: Aseptic meningitis
Maltese: Xokk anafilattiku
English: Although limited data is available, it is expected that the same interactions may occur in the paediatric population.
Maltese: Għalkemm dejta limitata hi disponibbli, huwa mistenni li fil-popolazzjoni pedjatrika jista' jkun hemm l-istess interazzjonijiet.
English: • 0.4 g/kg bw given daily for 2 to 5 days.
Maltese: 0.4 g/kg piż tal ġisem/kuljum għal 2 sa 5 ijiem
English: Immunoglobulin administration may impair for a period of at least 6 weeks and up to 3 months the efficacy of live attenuated virus vaccines such as measles, rubella, mumps, and varicella.
Maltese: L-għoti ta' l-immunoglobulina jista' jnaqqas għall-perijodu ta' mill-anqas 6 ġimgħat u sa 3 xhur l effikaċja ta' tilqim b'virus ħaj attenwat, bħal dawk kontra l-ħosba, il-ħosba Ġermaniża, il-gattone, u lġidri r-riħ.
English: For storage conditions after first opening of the medicinal product and after dilution, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara l-ewwel ftuħ tal-prodott mediċinali u wara d-dilwizzjoni, ara sezzjoni 6.3.
English: • Do not store above 25 °C.
Maltese: • Taħżinx f'temperatura 'l fuq minn 25°C.
English: Immunoglobulins are a normal constituent of the human body.
Maltese: L-immunoglobulini huma komponenti normali fil-ġisem tal-bniedem.
English: Somnolence, tremor
Maltese: Tqala u treddigħ
English: 1.6 to 2.0 g/kg bw should be administered in divided doses over 2 to 5 days or 2.0 g/kg bw as a single dose.
Maltese: 1.6 sa 2.0 g/kg piż tal-ġisem għandha tingħata f'dożi maqsuma fuq perijodu ta' minn 2 sa 5 ijiem jew 2.0 g/kg piż tal-ġisem bħala doża waħda.
English: • if you are allergic to human immunoglobulins or to proline.
Maltese: • jekk inti allerġiku għal immunoglobulini umani, jew għal proline.
English: Fatigue, asthenia (including muscular weakness) Common Injection site pain
Maltese: Għeja, astenja (inkluż dgħufija fil-muskoli)
English: For intravenous use.
Maltese: virus/infezzjonijiet.
English: Patients with chronic inflammatory demyelinating polyneuropathy (CIDP).
Maltese: Pazjenti li jbatu minn polinewropatija demajelinanti infjammatorja kronika (CIDP).
English: The recommended starting dose is 0.4 to 0.8 g/kg body weight (bw) given once, followed by at least 0.2 g/kg bw every 3 to 4 weeks.
Maltese: Id-doża inizjali rrakkomandata hi ta' 0.4 sa 0.8 g/kg piż tal-ġisem, tingħata darba biss segwita minn mill-inqas 0.2 g/kg piż tal-ġisem kull 3 sa 4 ġimgħat.
English: Organ mSv/MBq
Maltese: Organu mSv/MBq
English: After radiolabelling with sodium pertechnetate (
Maltese: Wara radjutikkettat b'soluzzjoni ta' sodium pertechnetate (
English: Effective Dose 0.00863 mSv / MBq
Maltese: Doża Effettiva 0.00863 mSv / MBq
English: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000)
Maltese: Komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1000 sa < 1/100) rari (≥ 1/10,000 sa < 1/1,000)
English: MBq ml hour/date
Maltese: MBq ml siegħa/data
English: Quality control
Maltese: Kontroll tal-kwalità
English: F-91192 Gif-sur-Yvette Cedex France
Maltese: F-91192 Gif-sur-Yvette Cedex Franza
English: Pregnancy (see section 4.6).
Maltese: Tqala (ara sezzjoni 4.6).
English: BATCH NUMBER Lot:
Maltese: NUMRU TAL-LOTT Lot:
English: After radiolabelling: 3 hours.
Maltese: Wara r-radjutikkettar: 3 sigħat.
English: Calculations
Maltese: Kalkulazzjonijiet
English: Cut the strip in two separate parts at Rf = 0.5.
Maltese: Aqta' l-istrippa f'żewġ partijiet separati f'Rf = 0.5.
English: Sodium dihydrogen phosphate, anhydrous Disodium monohydrogen phosphate, anhydrous Sorbitol E420
Maltese: Sodium dihydrogen phosphate, anidru Disodium monohydrogen phosphate, anidru Sorbitol E420
English: For patient preparation, see section 4.4.
Maltese: Għall-preparazzjoni tal-pazjent, ara sezzjoni 4.4.
English: The effective dose resulting from the administration of an activity of 800 MBq for an adult weighing 70 kg is 6.9 mSv.
Maltese: Id-doża effettiva li tirriżulta mill-għoti ta' attività ta' 800 MBq għal adult li jiżen 70 kg hi 6.9 mSv.
English: Individual benefit/risk justification
Maltese: Ġustifikazzjoni individwali tal-benefiċċju/riskju
English: Besilesomab is an anti-granulocyte monoclonal antibody (BW 250/183), produced in murine cells.
Maltese: Besilesomab huwa antikorp monoklonali antigranuloċita (BW 250/183), maħluq f'ċelluli murini.
English: Using a syringe, introduce through the rubber seal 5 mL of 0.9% sodium chloride solution.
Maltese: Permezz ta' siringa, daħħal minn ġos-siġill tal-lastku 5 ml ta' soluzzjoni ta' 0.9 % sodium chloride.
English: Human Anti-Mouse Antibodies (HAMA)
Maltese: Antikorpi Umani kontra l-Ġurdien (Human Anti-Mouse Antibodies, HAMA)
English: These three days correspond to 10 half-lives of technetium (99mTc) (60 hours).
Maltese: Tliet ijiem jikkorispondu għal 10 half-lives ta' technetium (99mTc) (60 siegħa).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/602/001 one multidose vial Scintimun and one vial solvent for Scintimun EU/1/09/602/002 two multidose vials Scintimun and two vials solvent for Scintimun
Maltese: EU/1/09/602/002 żewġ kunjetti ta' diversi dożi ta' Scintimun u żewġ kunjetti ta' solvent għal
English: % bound technetium (99mTc) = 100 % - % free Technetium (99mTc)
Maltese: % ta' technetium marbut (99mTc) = 100 % - % liberu Technetium (99mTc) fejn, % technetium liberu (99mTc) = Attività tal-istrippa maqtugħa minn Rf 0.5 sa Rf 1.0 x 100
English: The Marketing Authorisation Holder shall ensure that, at launch, all physicians experienced in nuclear medicine who are expected to prescribe/use Scintimun are provided with a Direct Healthcare Professional Communication (DHPC), which includes information regarding potential risks of human anti-mouse antibody (HAMA) generation, hypersensitivity reactions and risks of acute hypotension, as agreed by CHMP.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq għandu jiżgura li, mat-tnedija, it-tobba kollha b'esperjenza fil-mediċina nukleari li huma mistennija li jippreskrivu/jużaw Scintimun jiġu pprovduti b'Komunika Professjonali Diretta dwar il-Kura fil-Qasam tas-Saħħa (Direct Healthcare Professional Communication (DHPC)), li tinkludi informazzjoni dwar riskji potenzjali ta' ġenerazzjoni tal-antikorp uman kontra l-ġrieden (human anti-mouse antibody, HAMA), reazzjonijiet ta' sensittività eċċessiva u riskji ta' ipotensjoni akuta, kif miftiehem mill-Kumitat ghall-Prodotti Mediċinali għall-Użu Uman tal-Aġenzija Ewropea dwar il-Mediċini (CHMP).
English: Method Instant thin layer chromatography or paper chromatography.
Maltese: Metodu Kromatografija instantanja ta' saff irqieq jew kromatografija tal-karta
English: Technetium(99mTc) is a radioactive element allowing the organs where besilesomab accumulates to be seen using a special camera.
Maltese: Technetium(99mTc) huwa element radjuattiv li jippermetti l-organi jidhru b'kamera speċjali fejn ikun hemm akkumulazzjoni ta' besilesomab.
English: Excipients: Sodium dihydrogen phosphate anhydrous, disodium monohydrogen phosphate anhydrous, sorbitol, under nitrogen atmosphere.
Maltese: Scintimun Susutanzi mhux attivi : Sodium dihydrogen phosphate anidru, disodium monohydrogen phosphate anidru, sorbitol, nitrogen taħt atmosfera.
English: This corresponds to the administration of 0.25 to 1 mg of besilesomab.
Maltese: Dan jikkorispondi mal-għoti ta' 0.25 sa 1 mg ta' besilesomab.
English: Each vial of Scintimun contains 2 mg of sorbitol.
Maltese: Kull kunjett ta' Scintimun fih 2 mg ta' sorbitol.
English: Solvent for Scintimun
Maltese: Solvent għal Scintimun
English: After reconstitution with the solvent provided and the radiolabelling with sodium pertechnetate (99mTc) injection, the resulting clear and colourless solution for injection of technetium (99mTc)-besilesomab has a pH of 6.5-7.5.
Maltese: Wara r-rikostituzzjoni bis-solvent provdut u r-radjutikkettar b'injezzjoni ta' sodium pertechnetate (99mTc), is-soluzzjoni ċara u trasparenti għall-injezzjoni ta' technetium (99mTc) besilesomab li tirriżulta, għandha pH ta' 6.5-7.5.
English: The total volume in the vial of Scintimun equals 3 to 8 mL.
Maltese: Scintimun hu ugwali għal 3 sa 8 mL.
English: Under nitrogen atmosphere
Maltese: Nitrogen
English: - The final radiolabelled injection solution must be protected from oxygen.
Maltese: - Is-soluzzjoni radjutikkettata finali għall-injezzjoni għandha tkun protetta mill-ossiġenu.
English: In vitro, besilesomab cross-reacts with CEA.
Maltese: In vitro, besilesomab jirreaġixxi b'mod inkroċjat ma' CEA.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer of the biological active substance GLYCOTOPE Biotechnology GmbH
Maltese: Isem u indirizz tal-manifattur tas-sustanza bijoloġika attiva GLYCOTOPE Biotechnology GmbH Czerny-Ring, 22
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Maltese: Ir-rekwiżiti tar- rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tadDirettiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Non pathological unusual accumulations may be observed in the spleen (up to 6 % of the patients), in the bowel (up to 4 % of the patients), in the liver and bone marrow (up to 3 % of the patients), and in the thyroid and kidneys (up to 2 % of patients).
Maltese: (sa 4 % tal-pazjenti), fil-fwied u fil-mudullun (sa 3 % tal-pazjenti), u fit-tirojdi u l-kliewi (sa 2 % tal-pazjenti).
English: Do not store above 25 °C after radiolabelling.
Maltese: Taħżinx f'temperatura 'l fuq minn 25 °C wara r-radjutikkettar.
English: Hypersensitivity to the active substance, to other murine antibodies, to any of the excipients listed in section 6.1 or to any of the components of the labelled radiopharmaceutical.
Maltese: Sensittività eċċessiva għas-sustanza attiva, għal antikorpi murini oħra, għal kwalunkwe wieћed milleċċipjenti elenkati fis-sezzjoni 6.1 jew għal kwalunkwe wieħed mill-komponenti tal-prodott mediċinali radjutikkettat.
English: Rare (may affect up to 1 in 1,000 people):
Maltese: Rari (jista' jaffettwa sa 1 minn kull 1,000 persuna):
English: An additional acquisition 24 hours after initial injection is recommended.
Maltese: 24 siegħa wara l-injezzjoni inizjali hi rakkomandata.
English: Sodium hydroxide / Hydrochloric acid (for pH adjustment) Nitrogen
Maltese: Sodium hydroxide / Hydrochloric acid (għall-aġġustament tal-pH)
English: 15 mL, colourless, type I glass vial, closed with chlorobutyl rubber stopper and crimped aluminium capsule (yellow) containing 2.82 mg of powder.
Maltese: 15 mL, kunjett tal-ħġieġ ta' tip I mingħajr kulur, magħluq b'tapp tal-lastku ta' chlorobutyl u kapsula ppjegata tal-aluminju (safra) li fih 2.82 mg ta' trab.
English: Whole body
Maltese: Hemm lig
English: Scintimun 1 mg kit for radiopharmaceutical preparation besilesomab
Maltese: Scintimun 1 mg sett għall-preparazzjoni radjufarmaċewtika besilesomab
English: 15 mL, colourless, type I glass vial, closed with chlorobutyl rubber stopper and aluminium crimped capsule (green) containing 5.02 mg of powder.
Maltese: 15 mL, mingħajr kulur, kunjett tal-ħġieġ tip I, magħluq b'tapp tal-lastku ta' chlorobutyl u kapsula ppjegata tal-aluminju (ħadra) li fih 5.02 mg ta' trab.
English: Twenty-four hours after injection, the percentages of radioactivity are 1.6 % in the liver and 2.3 % in the spleen.
Maltese: Erbgħa u għoxrin siegħa wara l-injezzjoni, dawn il-persentaġġi tar radjuattività ikunu 1.6 % fil-fwied u 2.3 % fil-milsa.
English: Scintimun contains sorbitol and sodium
Maltese: Scintimun fih sorbitol u Sodju'
English: The recommended activity of technetium (99mTc) besilesomab should be between 400 MBq and
Maltese: L-attività rakkomandata ta' technetium (99mTc) besilesomab għandha tkun ta' bejn 400 MBq u
English: Rf to
Maltese: TAGĦRIF
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator (2 °C - 8 °C).
Maltese: 6.4 Prekawzjonijiet speċjali għall-ħażna Aħżen fi friġġ (2 °C - 8 °C).
English: Marketing Authorisation Holder and Manufacturer CIS bio international
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-tqegħid fis-Suq u l-Manifattur CIS bio international
English: For diagnostic nuclear medicine investigations the frequency of these adverse reactions is not known.
Maltese: Għal stħarriġ dijajostiku bil-mediċina nukleari l-frekwenza ta' dawn irreazzjonijiet avversi mhix magħrufa.
English: In the most recent clinical study in which 123 patients were administered Scintimun, the most commonly reported adverse reaction was the development of anti-mouse antibodies (HAMA) in 14 % of the patients, after a single administration (16 positive over 116 assayed one and/or three months after the administration).
Maltese: Fl-aħħar studji kliniċi riċenti li fihom 123 pazjent ingħataw Scintimun, l-aktar reazzjoni avversa kommunament rapportata kienet l-iżvilupp ta' antikorpi ta' kontra l-ġurdien (HAMA) f'14% talpazjenti, wara amministrazzjoni waħda (16 pożittivi wara 116-il pazjent analizzati wara xahar u/jew tliet xhur wara l-għoti).
English: Ph.).
Maltese: Tc).
English: Tc) besilesomab solution obtained is indicated in adults for scintigraphic imaging, in conjunction with other appropriate imaging modalities, for determining the location of inflammation/infection in peripheral bone in adults with suspected osteomyelitis.
Maltese: Tc)- besilesomab li tiġi ottenuta hija indikata fl-adulti għall-immaġini xintigrafiċi, flimkien ma' modalitajiet oħra xierqa ta' immaġini, sabiex tiġi lokalizzata l-infjammazzjoniji/l-infezzjoni f'għadam periferali f'adulti b'osteomajlite suspettata.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTUR TAS-SUSTANZA BIJOLOĠIKA ATTIVA U MANIFATTUR RESPONSABBLI
English: Apply a spot (2 µL) of the radiolabelled solution to the starting line of the ITLC-SG or RBM-1 paper strip using a syringe and a needle.
Maltese: Applika qatra (2 µL) tas-soluzzjoni radjutikkettata mal-linja tal-bidu fuq l-istrippa tal-karta ta' ITLC-SG jew RBM-1 permezz ta' siringa u labra.
English: Transfer 1 mL of this solution with a hypodermic syringe into a vial of Scintimun (green crimped aluminium capsule).
Maltese: Ittrasferixxi 1 mL ta' din is-soluzzjoni b'siringa ipodermika ġo kunjett ta' Scintimun (kapsula tal-aluminju ħadra u pjegata).
English: Scintimun: white powder Solvent for Scintimun: white powder
Maltese: Solvent għal Scintimun: trab abjad