FrancophonIA/ELRC3.0 huggingface dataset:
English: The blister materials consist of a four layer aluminum foil laminate cold form blister film and a paper backed laminated aluminum foil lidding film.
Maltese: Il-materjali tal-folji huma magħmula minn erba' saffi ta' fojl ta' aluminium laminat fil-forma kiesħa għar-rita tal-folja u fojl tal-aluminium miksi b'karta laminata minn wara għar-rita biex tagħlaq.
English: SE-141 75 Kungens Kurva Sweden
Maltese: SE-141 75 Kungens Kurva
English: Oral suspension 90 ml
Maltese: Suspensjoni orali 90 ml
English: Capsule shell gelatin titanium dioxide (E 171)
Maltese: Qoxra tal-kapsula gelatin titanium dioxide (E 171)
English: Capsule content Starch, pregelatinised (maize)
Maltese: Kontenut tal-kapsula Starch pregelatinised (maize)
English: Orfadin contains sodium, glycerol and sodium benzoate
Maltese: Orfadin fih sodium, glycerol u sodium benzoate
English: Date of first authorisation: 21 February 2005 Date of latest renewal: 19 January 2010
Maltese: Data tal-aħħar tiġdid: 21 ta' Jannar 2010
English: Dose Orfadin mg ml
Maltese: Orfadin mg mL
English: Excipients with known effect: Each ml contains: sodium 0.7 mg (0.03 mmol) glycerol 500 mg sodium benzoate 1 mg
Maltese: Kull mL fih sodium 0.7 mg (0.03 mmol) glycerol 500 mg sodium benzoate 1 mg
English: Data from a study used as a historical control (van Spronsen et al., 1994) showed the following survival probability.
Maltese: Dejta minn studju użata bħala kontroll storiku (van Spronsen et al., 1994) uriet il-probabbiltà ta'
English: 4 mg/ml oral suspension:
Maltese: 4 mg/mL suspensjoni orali:
English: Figure F.
Maltese: Figura F.
English: Store upright.
Maltese: Żommu wieqaf.
English: Oral suspension 1 bottle of 90 ml, 1 bottle adaptor, 3 oral syringes (1 ml, 3 ml, 5 ml).
Maltese: Suspensjoni orali 1 flixkun ta' 90 ml, 1 adapter ta' flixkun, 3 siringi tal-ħalq (1 ml, 3 ml, 5 ml).
English: Printing ink black iron oxide (E 172) shellac propylene glycol ammonium hydroxide
Maltese: Linka tal-istampar black iron oxide (E 172) shellac propylene glycol idrossidu tal-ammonju
English: 2 mg, 5 mg, 10 mg and 20 mg hard capsules:
Maltese: 2 mg, 5 mg, 10 mg u 20 mg kapsuli ibsin:
English: In vitro studies using human liver microsomes and cDNA-expressed P450 enzymes have shown limited CYP3A4-mediated metabolism.
Maltese: Studji in vitro bl-użu ta' mikrosomi tal-fwied uman u enzimi cDNA-expressed P450 urew metaboliżmu limitat medjat minn CYP 3A4.
English: - The other ingredients are hydroxypropylmethylcellulose, glycerol (see section 2), polysorbate 80, sodium benzoate (E211) (see section 2), citric acid monohydrate, sodium citrate (see section 2), strawberry aroma (artificial) and purified water.
Maltese: polysorbate 80, sodium benzoate (E211) (ara sezzjoni 2), citric acid monohydrate, sodium citrate (ara sezzjoni 2), aroma tal-frawli (artifiċjali) u ilma ppurifikat.
English: Sodium Each ml contains 0.7 mg (0.03 mmol).
Maltese: Kull mL fih 0.7 mg (0.03 mmol).
English: Strawberry aroma (artificial) Purified water
Maltese: Aroma tal-frawli (artifiċjali)
English: 5 mg, 10 mg, 20 mg: Store in a refrigerator.
Maltese: 5 mg, 10 mg, 20 mg: Aħżen fi friġġ.
English: The active ingredient of Orfadin is nitisinone.
Maltese: Is-sustanza attiva ta' Orfadin hija nitisinone.
English: Figure A.
Maltese: Figura A.
English: Orfadin 4 mg/ml oral suspension Nitisinone
Maltese: Orfadin 4 mg/ml suspensjoni orali Nitisinone
English: The bottle should be shaken vigourously for at least 5 seconds (Figure D).
Maltese: Il-flixkun għandu jitħawwad bis-saħħa għal tal-anqas 5 sekondi (Figura D). 2.
English: Figure C.
Maltese: Figura C.
English: Figure B.
Maltese: Figura B.
English: Figure E.
Maltese: Figura E.
English: Available data from a clinical study indicates that in more than 90% of the patients urine succinylacetone was normalized during the first week of treatment.
Maltese: Dejta disponibbli minn studju kliniku tindika li iktar minn 90% ta' succinylacetone fl awrina tal-pazjenti kien normalizzat matul l-ewwel ġimgħa tal-kura.
English: Figure D.
Maltese: Figura D.
English: Printing ink: iron oxide (E 172) shellac propylene glycol ammonium hydroxide
Maltese: ġelatina titanium dioxide (E 171) Linka tal-istampar: iron oxide (E 172) shellac propylene glycol idrossidu tal-ammonju
English: Orfadin 4 mg/ml oral suspension
Maltese: Orfadin 4 mg/mL suspensjoni orali
English: Fertility There are no data on nitisinone affecting fertility.
Maltese: Fertilità M'hemm ebda dejta dwar netisinone li taffettwa l-fertilità.
English: 1 ml contains 4 mg nitisinone.
Maltese: 1 mL fih 4 mg nitisinone.
English: Do not breast-feed while taking this medicine, see section “Do not take Orfadin”.
Maltese: Treddax waqt li tkun qed tieħu din il-mediċina, ara s- sezzjoni “Tiħux Orfadin”.
English: Orfadin 20 mg: Each capsule contains 20 mg nitisinone.
Maltese: Orfadin 20 mg: Kull kapsula fiha 20 mg ta' nitisinone.
English: The oral suspension is a white, slightly thicker opaque suspension.
Maltese: Is-suspensjoni orali hi suspensjoni opaka bajda ftit eħxen.
English: Orfadin 5 mg: Each capsule contains 5 mg nitisinone.
Maltese: Orfadin 5 mg: Kull kapsula fiha 5 mg ta' nitisinone.
English: Furosemide AUC∞ was increased 1.7-fold, indicating a weak inhibition of OAT1/OAT3 (see sections 4.4 and 4.5).
Maltese: L-AUC∞ ta' furosemide żdiedet b'1.7 darbiet, u dan jindika inibizzjoni dgħajfa ta' OAT1/OAT3 (ara sezzjonijiet 4.4 u 4.5).
English: If the levels are markedly higher than they should be, especially in prematures babies with risk factors as acidosis (too low pH in the blood) and low albumin level (a protein in the blood) treatment with Orfadin capsules will be considered instead of the oral suspension until the bilirubin plasma levels are normalised.
Maltese: b'mod speċjali fi trabi prematuri b'fatturi ta' riskju bħal aċidożi (pH baxx wisq fid-demm) u livell baxx ta' albumina (proteina fid-demm), tiġi kkunsidrata l-kura bil-kapsuli Orfadin minflok suspensjoni orali sakemm il-livelli ta' bilirubin fil-plasma jiġu normalizzati.
English: Other uncommon side effects - increased number of white blood cells (leucocytosis), - itching (pruritus), skin inflammation (exfoliative dermatitis), rash.
Maltese: Effetti sekondarji mhux komuni oħra żieda fin-numru ta' ċelloli bojod tad-demm (lewkoċitosi), ħakk (prurite), infjammazzjoni tal-ġilda (dermatite sfoljattiva), raxx.
English: How to take Orfadin
Maltese: X'fih Orfadin
English: Each bottle contains 90 ml oral suspension.
Maltese: Kull flixkun fih 90 mL suspensjoni orali.
English: A pre- and postnatal development study in the mouse showed statistically significantly reduced pup survival and pup growth during the weaning period at dose levels 125- and 25-fold higher, respectively, than the maximum recommended human dose, with a trend toward a negative effect on pup survival starting from the dose of 5 mg/kg/day.
Maltese: Studju dwar l-iżvilupp ta' qabel u wara t-twelid fil-ġrieden wera sopravivenza u t-tkabbir tal-frieħ matul il-perjodu tal-ftim, li kienu mnaqqsa b'mod statistikament sinifikanti f'livelli ta' doża 125 u 25 darba ogħla, rispettivament, mid-doża massima rakkomandata fil-bniedem, b'tendenza lejn effett negattiv tas-sopravivenza tal-frieħ li jibda mid-doża ta' 5 mg/kg/kuljum.
English: Orfadin 2 mg: Each capsule contains 2 mg nitisinone.
Maltese: Orfadin 2 mg: Kull kapsula fiha 2 mg ta' nitisinone.
English: 1-ml oral syringe (0.01 ml graduation)
Maltese: (gradwazzjoni ta' 0.01 mL)
English: The oral syringes are graduated in 0.01 ml, 0.1 ml and 0.2 ml steps respectively.
Maltese: Is-siringi tal-ħalq huma ggradati fi stadji ta' 0.01 mL, 0.1 mL u 0.2 mL rispettivament.
English: This medicinal product contains 0.7 mg (0.03 mmol) sodium per ml.
Maltese: Dan il-prodott mediċinali fih 0.7 mg (0.03 mmol) ta' sodium f'kull mL.
English: Orfadin 10 mg: Each capsule contains 10 mg nitisinone.
Maltese: Orfadin 10 mg: Kull kapsula fiha 10 mg ta' nitisinone.
English: In patients with HT-1, these intermediates are converted to the toxic metabolites succinylacetone and succinylacetoacetate.
Maltese: F'pazjenti b'HT-1, dawn l-intermedji jinbidlu għal metaboliti tossiċi succinylacetone u succinylacetoacetate.
English: Data is, however, limited in patients with body weight <20 kg.
Maltese: Madankollu, id-dejta hi limitata f'pazjenti b'piż tal-ġisem ta' <20 kg.
English: A more restricted tyrosine and phenylalanine diet should be implemented in case the plasma tyrosine level is above 500 micromol/l.
Maltese: Dieta iktar ristretta ta' tyrosine u phenylalanine għandha tiġi implimentata fil-każ li l-livell ta' tyrosine fil-plażma jkun iktar minn 500 micromol/L.
English: Orfadin is also available as a 4 mg/ml oral suspension for paediatric patients who have difficulties swallowing capsules.
Maltese: Orfadin huwa disponibbli wkoll bħala suspensjoni orali ta' 4 mg/mL għal pazjenti pedjatriċi li jkollhom diffikultajiet biex jibilgħu l-kapsuli.
English: Age at onset of symptoms 1 year 2 years < 2 months > 2-6 months > 6 months
Maltese: Età fil-bidu tas-sintomi Sena Sentejn < xahrejn > 2-6 xhur > 6 xhur
English: Each capsule contains 20 mg nitisinone.
Maltese: Kull kapsula fiha 20 mg ta' nitisinone.
English: A 1 ml, 3 ml and 5 ml oral syringes are included in the pack to measure the dose in ml in accordance with the prescribed posology.
Maltese: 1 mL, 3 mL u 5 mL huma inklużi fil-pakkett biex ikejlu d-doża f'mL skont il-pożoloġija mogħtija mittabib.
English: Orfadin may interfere with the effect of other medicines, such as: - Medicines for epilepsy (such as phenytoin) - Medicines against blood clotting (such as warfarin)
Maltese: - Mediċini għall-epilessija (bħal phenytoin) - Mediċini kontra t-tagħqid tad-demm (bħal warfarin)
English: A dose of 20 ml oral suspension (10 g glycerol) or more may cause headache, stomach upset and diarrhoea.
Maltese: Doża ta' 20 mL suspensjoni orali (10 g ta' glycerol) jew aktar tista' tikkawża wġigħ ta' ras, dardir u dijarrea.
English: • The 5 ml oral syringe (the largest oral syringe), is marked from 1 ml to 5 ml with minor 0.2-ml graduations.
Maltese: • Is-siringa tal-ħalq ta' 5 mL (l-akbar siringa tal-ħalq), hija mmarkata minn 1 mL sa 5 mL bi gradwazzjonijiet minuri ta' 0.2 mL.
English: Cleaning
Maltese: Manifattur
English: Cleaning:
Maltese: Tindif:
English: Bilirubin levels should be measured before start of treatment: in case of markedly elevated plasma levels of bilirubin, especially in premature patients with risk factors as acidosis and low albumin level, treatment with an appropriately weighed portion of an Orfadin capsule should be considered instead of the oral suspension until the unconjugated bilirubin plasma levels are normalised.
Maltese: Fil-każ ta' livelli għoljin b'mod sinifikanti ta' bilirubin fil-plasma, b'mod speċjali f'pazjenti prematuri b'fatturi ta' riskju bħal aċidożi u livell baxx ta' albumina, għandha tiġi kkunsidrata kura b'porzjon miżun b'mod xieraq ta' kapsula ta' Orfadin minflok sospensjoni orali sakemm il-livelli ta' bilirubin fil-plasma mhux konjugati jiġu normalizzati.
English: Orfadin must not be injected.
Maltese: Orfadin m'għandux jiġi injettat.
English: Excipients with known effect:
Maltese: Jekk tesperjenza xi effetti sekondarji,
English: From clinical study and post marketing data there are no indications that the safety profile is different in different subsets of the paediatric population or different from the safety profile in adult patients.
Maltese: Minn studju kliniku u dejta ta' wara t-tqegħid fis-suq m'hemm ebda indikazzjoni li l-profil tas-sigurtà huwa different f'subsettijiet differenti ta' popolazzjoni pedjatrika jew differenti mill-profil tas-sigurtà f'pazjenti adulti.
English: 2 mg: Store in a refrigerator.
Maltese: 2 mg: Aħżen fi friġġ.
English: Shake off excess water and leave the disassembled oral syringe to dry until reassemble for next dosing occasion.
Maltese: Reazzjonijiet avversi komuni oħra jinkludu tromboċitopenja, lewkopenja, u granuloċitopenija.
English: Orfadin is also available in 2 mg, 5 mg, 10 mg and 20 mg capsules, if considered more suitable for the patient.
Maltese: Orfadin huwa disponibbli wkoll f'kapsuli ta' 2 mg, 5 mg, 10 mg u 20 mg, jekk jiġi kkunsidrat li hu aktar adattat għall-pazjent.
English: Tabulated list of adverse reactions The adverse reactions listed below by MedDRA system organ class and absolute frequency, are based on data from a clinical trial and post-marketing use.
Maltese: Ir-reazzjonijiet avversi elenkati hawn taħt skont is-sistema tal-klassifika tal-organi MedDRA u skont il-frekwenza assoluta, huma bbażati fuq dejta minn prova klinika u wara l-użu għat-tqegħid fis-suq.
English: Each pack contains one bottle, one LDPE bottle adapter and 3 polypropylene (PP) oral syringes (1 ml, 3 ml and 5 ml).
Maltese: Kull pakkett fih flixkun wieħed, adapter tal-flixkun tal-LDPE wieħed u 3 siringi tal-ħalq tal polypropylene (PP) (1 mL, 3 mL u 5 mL).
English: • The 3 ml oral syringe (the middle sized oral syringe), is marked from 1 ml to 3 ml with minor 0.1-ml graduations.
Maltese: • Is-siringa tal-ħalq ta' 3 mL (is-siringa tal-ħalq tad-daqs tan-nofs), hija mmarakata minn 1 mL sa 3 mL bi gradwazzjonijiet minuri ta' 0.1 mL.
English: A population pharmacokinetic analysis has been conducted on a group of 207 HT-1 patients.
Maltese: 207 pazjenti li kellhom l-HT-1.
English: • The 1-ml oral syringe (the smallest oral syringe) is marked from 0.1 ml to 1 ml with minor 0.01-ml graduations.
Maltese: • Is-siringa tal-ħalq ta' 1 mL (l-iżgħar siringa tal-ħalq) hija mmarkata minn 0.1 mL sa 1 mL bi gradwazzjonijiet minuri ta' 0.01 mL.
English: Therefore, mothers receiving nitisinone must not breast-feed, since a risk to the suckling child cannot be excluded (see sections 4.3 and 5.3).
Maltese: ommijiet li jkunu qed jieħdu nitisinone m'għandhomx ireddgħu, għax ir-riskju lit-tarbija li tkun qed terda' ma jistax jiġi eskluż (ara sezzjonijiet 4.3 u 5.3).
English: Orfadin 2 mg hard capsules Orfadin 5 mg hard capsules Orfadin 10 mg hard capsules Orfadin 20 mg hard capsules nitisinone
Maltese: Orfadin 2 mg kapsuli iebsin Orfadin 5 mg kapsuli iebsin Orfadin 10 mg kapsuli iebsin Orfadin 20 mg kapsuli iebsin nitisinone
English: Orfadin 2 mg hard capsules Orfadin 5 mg hard capsules Orfadin 10 mg hard capsules Orfadin 20 mg hard capsules Nitisinone
Maltese: Orfadin 2 mg kapsuli iebsin Orfadin 5 mg kapsuli iebsin Orfadin 10 mg kapsuli iebsin Orfadin 20 mg kapsuli iebsin Nitisinone
English: White, opaque capsules (6x16 mm) imprinted “NTBC 20mg” in black on the body of the capsule.
Maltese: Kapsuli bojod, opaki (6x16 mm), stampati b'“NTBC 20mg” bl-iswed fuq il-parti ta' barra tal-kapsula.
English: Important information about instructions for use:
Maltese: Informazzjoni importanti dwar l-istruzzjonijiet għall-użu:
English: 5-ml oral syringe (0.2 ml graduation)
Maltese: (gradwazzjoni ta' 0.2 mL)
English: White, opaque capsules (6x16 mm) imprinted “NTBC 5mg” in black on the body of the capsule.
Maltese: Kapsuli bojod, opaki (6x16 mm), stampati b'“NTBC 5mg” bl-iswed fuq il-parti ta' barra tal-kapsula.
English: 3-ml oral syringe (0.1 ml graduation)
Maltese: (gradwazzjoni ta' 0.1 mL)
English: Each ml contains 1 mg. Increase in bilirubin following its displacement from albumin, caused by benzoic acid and its salts, may increase jaundice in pre-term and full-term jaundiced neonates and develop into kernicterus (unconjugated bilirubin deposits in the brain tissue).
Maltese: Żieda fil-bilirubin wara l-istakkar tiegħu mill-albumina, ikkawżata minn benzoic acid u l-imluħa tiegħu, tista' żżid is-suffejra fi trabi tat-twelid bis-suffejra li jitwieldu qabel iż-żmien u dawk li jitwieldu wara l-perjodu normali ta' tqala u tista' tiżviluppa f'kernikterus (depożiti ta' bilirubin mhux konjugati fit-tessut tal-moħħ).
English: Orfadin 2 mg hard capsules Orfadin 5 mg hard capsules Orfadin 10 mg hard capsules Orfadin 20 mg hard capsules
Maltese: Orfadin 2 mg kapsuli iebsin Orfadin 5 mg kapsuli iebsin Orfadin 10 mg kapsuli iebsin Orfadin 20 mg kapsuli iebsin
English: The pack contains a bottle of medicine with a cap, a bottle adaptor and three oral syringes (1 ml, 3 ml and 5 ml).
Maltese: Il-pakkett fih flixkun ta' mediċina b'għatu, adapter tal-flixkun u tliet siringi tal-ħalq (1 mL, 3 mL u 5 mL).
English: Elevated levels of tyrosine have been associated with eye-related adverse reactions, such as e.g. corneal opacities and hyperkeratotic lesions.
Maltese: Livelli għoljin ta' tyrosine kienu assoċjati ma' tossiċità tal-għajnejn, tal-ġilda, u tas-sistema nervuża.
English: White, opaque capsules (6x16 mm) imprinted “NTBC 2mg” in black on the body of the capsule.
Maltese: Kapsuli bojod, opaki (6x16 mm), stampati b'“NTBC 2mg” bl-iswed fuq il-parti ta' barra tal-kapsula.
English: White, slightly viscous opaque suspension.
Maltese: Suspensjoni opaka bajda, ftit viskuża.
English: White, opaque capsules (6x16 mm) imprinted “NTBC 10mg” in black on the body of the capsule.
Maltese: Kapsuli bojod, opaki (6x16 mm), stampati b'“NTBC 10mg” bl-iswed fuq il-parti ta' barra tal-kapsula.
English: The hard capsules are white, opaque, imprinted with “NTBC” and the strength “2 mg”, “5 mg”, “10 mg” or “20 mg”, in black.
Maltese: Il-kapsuli huma bojod, opaki, ibsin u magħmula minn ġelatina, bil-kliem “NTBC” u l-qawwa “2 mg”,
English: Each capsule contains 2 mg nitisinone Each capsule contains 5 mg nitisinone Each capsule contains 10 mg nitisinone Each capsule contains 20 mg nitisinone
Maltese: Kull kapsula fiha 2 mg ta' nitisinone Kull kapsula fiha 5 mg ta' nitisinone Kull kapsula fiha 10 mg ta' nitisinone Kull kapsula fiha 20 mg ta' nitisinone
English: During the shelf life, the patient may store the capsules for a single period of 2 months (for 2 mg capsules) or 3 months (for 5 mg, 10 mg and 20 mg capsules) at a temperature not above 25°C, after which the medicinal product must be discarded.
Maltese: Il-prodott jista' jinħażen għal perjodu wieħed ta' xahrejn (għall-kapsula ta' 2 mg) jew 3 xhur (għallkapsuli ta' 5 mg, 10 mg u 20 mg) f'temperatura ta' mhux iktar minn 25°C, u wara dan, għandu jintrema.
English: If urine succinylacetone is still detectable one month after the start of nitisinone treatment, the nitisinone dose should be increased to 1.5 mg/kg body weight/day.
Maltese: Jekk succinylacetone flawrina jkun jista' jiġi osservat wara xahar mill-bidu tal-kura b'nitisinone, id-doża ta' nitisinone għandha tiżdied għal 1.5 mg/kg ta' piż tal-ġisem / kuljum.
English: Adverse reactions involving the eyes (see section 4.8) can affect the vision.
Maltese: Reazzjonijiet avversi li jinvolvu lgħajnejn (ara sezzjoni 4.8) jistgħu jaffettwaw il-vista.
English: Dose conversion tables respectively for the three oral syringe sizes:
Maltese: Tabelli tal-konverżjoni tad-doża rispettivament għat-tliet daqsijiet ta' siringi tal-ħalq:
English: 1 capsule
Maltese: 1 kapsula
English: 4 x 1 capsules (unit dose)
Maltese: 4 x 1 kapsuli (doża waħda)
English: Further information on Lumark can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: Aktar informazzjoni dwar Lumark tinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Lumark
Maltese: Informazzjoni oħra dwar Lumark
English: Lumark received a marketing authorisation valid throughout the EU on 19 June 2015.
Maltese: Lumark irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fid-19 ta' Ġunju 2015.
English: What are the risks associated with Lumark?
Maltese: X'inhuma r-riskji assoċjati ma' Lumark?
English: The most common side effects with Lumark (which may affect more than 1 in 10 people) are anaemia (low red blood cell counts), thrombocytopenia (low blood platelet counts), leucopenia (low white blood cell counts), lymphopenia (low levels of lymphocytes, a particular type of white blood cell), nausea (feeling sick), vomiting and mild and temporary hair loss.
Maltese: L-effetti sekondarji l-aktar komuni b'Lumark (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma anemija (għadd baxx ta' ċelloli ħomor tad-demm), tromboċitopenja (għadd baxx ta' pjastrini tad-demm), lewkopenija (għadd baxx ta' ċelloli bojod tad-demm), limfopenija (livelli baxxi ta' limfoċiti, tip partikolari ta' ċellola bajda tad-demm), nawsja (tħossok ma tiflaħx), rimettar u telf tax-xagħar ħafif u temporanju.
English: As for all medicines, data on the use of Lumark are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Lumark hija ssorveljata kontinwament.
English: Radiolabelling with Lumark takes place in a laboratory.
Maltese: Ir-radjotikkettar b'Lumark iseħħ f'laboratorju.
English: Lu) chloride)
Maltese: Lumark (lutetium (177Lu) chloride)
English: The active substance in Lumark, lutetium (177Lu) chloride, is a radioactive compound that mainly releases beta radiation, with small amounts of gamma radiation.
Maltese: Is-sustanza attiva f'Lumark, il-lutetium (177Lu) chloride, hija kompost radjuattiv li prinċipalment jirrilaxxa radjazzjoni beta, b'ammonti żgħar ta' radjazzjoni gamma.
English: As with all radiolabelling materials for medicines, there are risks linked to radiation exposure from Lumark.
Maltese: Fir-rigward ta' kull materjal ta' radjotikkettar għall-mediċini, hemm riskji marbuta mal-esponiment ta' radjazzjoni minn Lumark.
English: Several published studies have established the usefulness of lutetium (177Lu) in radiolabelling medicines for diagnosing and treating neuroendocrine tumours.
Maltese: Diversi studji ppubblikati stabbilixxew l-utilità tallutetium (177Lu) fir-radjotikkettar ta' mediċini għad-dijanjożi u għall-kura ta' tumuri newroendokrinali.
English: Lumark contains the radioactive compound lutetium (177Lu) chloride and is used for radiolabelling other medicines.
Maltese: Lumark fih il-kompost radjuattiv lutetium (177Lu) chloride u jintuża għar-radjotikkettar ta' mediċini oħrajn.
English: These tumours affect hormone-secreting cells in many parts of the body, including the pancreas, intestine, stomach and lungs.
Maltese: Dawn it-tumuri jaffettwaw iċ-ċelloli li jirrilaxxaw l-ormoni f'bosta partijiet tal-ġisem, inkluż il-frixa, limsaren, l-istonku u l-pulmun.
English: Because the use of lutetium (177Lu) to radiolabel medicines is well established, the company presented data from the scientific literature.
Maltese: Peress li l-użu tal-lutetium (177Lu) għar-radjotikkettar ta' mediċini huwa stabbilit sew, il-kumpanija ppreżentat data mid-dokumentazzjoni xjentifika.
English: Information on how to minimise the risks is included in the product information for Lumark.
Maltese: Informazzjoni dwar kif għandhom jitnaqqsu r-riskji hija inkluża fl-informazzjoni dwar il-prodott għal Lumark.
English: Radiolabelling is a technique for tagging (or labelling) medicines with radioactive compounds so they can carry radioactivity to where it is needed in the body, for example, the site of a tumour.
Maltese: Ir-radjotikkettar hija teknika għall-immarkar (jew it-tikkettar) ta' mediċini b'komposti radjuattivi biex b'hekk ikunu jistgħu jġorru r-radjuattività għal fejn tkun meħtieġa fil-ġisem, pereżempju, is-sit ta' tumur.
English: Lumark is to be used to radiolabel medicines that have been specifically developed for use with lutetium (177Lu) chloride.
Maltese: Lumark għandu jintuża għar-radjotikkettar tal-mediċini li jkunu ġew żviluppati speċifikament għall-użu b'lutetium (177Lu) chloride.
English: Side effects reported with Lumark are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Lumark huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: The radiolabelled medicine is then given to the patient according to the instructions in that medicine's product information.
Maltese: Imbagħad ilmediċina radjotikkettata tingħata lill-pazjent skont l-istruzzjonijiet fl-informazzjoni dwar il-prodott ta' dik il-mediċina.
English: The European Medicines Agency considered that the use of lutetium (177Lu) for radiolabelling medicines was well established and well documented in the scientific literature.
Maltese: L-Aġenzija Ewropea għall-Mediċini kkunsidrat li l-użu ta' lutetium (177Lu) għar-radjotikkettar talmediċini kien stabbilit sew u ddokumentat sew fid-dokumentazzjoni xjentifika.