FrancophonIA/ELRC3.0 huggingface dataset:
English: Limited studies have been conducted in patients under 4 years of age with BH4 deficiency using another formulation of the same active substance (sapropterin) or an un-registered preparation of BH4.
Maltese: Studji ristretti ġew imwettqa f'pazjenti ta' inqas minn 4 snin li kellhom id-defiċjenza BH4, fejn ġiet użata formulazzjoni oħra tal-istess sustanza attiva (sapropterin) jew preparazzjoni mhux reġistrata ta' BH4.
English: Kuvan 500 mg powder for oral solution Sapropterin dihydrochloride
Maltese: Kuvan 500 mg trab għal soluzzjoni orali Sapropterin dihydrochloride
English: Give your child the prescribed amount of solution within 15 to 20 minutes after dissolving.
Maltese: Is-soluzzjoni għandha tinxtorob mhux aktar tard minn 15 sa 20 minuta minn meta tkun ġiet ippreparata.
English: After 3-weeks of treatment with sapropterin dihydrochloride 20 mg/kg/day, blood phenylalanine levels were significantly reduced; the mean ± SD decrease from baseline in blood phenylalanine level within this group was 149 ± 134 μmol/l (p<0.001).
Maltese: Wara kura ta' 3 ġimgħat b'sapropterin dihydrochloride 20 mg/kg/kuljum, f'dan il-grupp, il-livelli ta' phenylalanine fid-demm ġew imnaqqsa b'mod sinifikanti: it-tnaqqis ± SD fil-medja mill-linja bażi fillivelli ta' phenylalanine fid-demm f'dak il-grupp kien ta' 149 ± 134 μmol/l (p < 0.001).
English: In the clinical trial extension period, patients maintained dietary phenylalanine tolerance while on Kuvan treatment in conjunction with a Phe-restricted diet, demonstrating sustained benefit over 3.5 years.
Maltese: Fil-perjodu ta' estensjoni tal-prova klinika, il-pazjenti żammew tolleranza ta' phenylalanine fid-dieta waqt it-trattament b'Kuvan flimkien ma' dieta ristretta ta' phenylalanine, xhieda ta' benefiċċju sostnut fuq medda ta' 3.5 snin.
English: • Place the prescribed number of Kuvan 100 mg sachets in the medicine cup.
Maltese: • Poġġi n-numru ta' qratas ta' Kuvan 100 mg li għalihom ingħatat riċetta fit-tazza tal-mediċina.
English: Doses may be adjusted up to a total of 20 mg/kg per day.
Maltese: Id-dożi jistgħu jiġu aġġustati sa total ta' 20 mg/kg/kuljum.
English: Kuvan is also indicated for the treatment of hyperphenylalaninaemia (HPA) in adults and paediatric patients of all ages with tetrahydrobiopterin (BH4) deficiency who have been shown to be responsive to such treatment (see section 4.2).
Maltese: Kuvan huwa indikat ukoll għal-kura ta' hyperphenylalaninaemia (HPA) f'adulti u pazjenti pedjatrici ta' kull età b'defiċjenza ta' tetrahydrobiopterin (BH4), u li jkunu wrew rispons għal din il-kura (ara sezzjoni 4.2).
English: Although concomitant administration of inhibitors of dihydrofolate reductase (e.g. methotrexate, trimethoprim) has not been studied, such medicinal products may interfere with BH4 metabolism.
Maltese: Methotrexate, trimethoprim) ma' ġiex studjat, dawn il-prodotti mediċinali jistgħu jfixklu l-metaboliżmu BH4.
English: Kuvan 100 mg powder for oral solution Sapropterin dihydrochloride
Maltese: Kuvan 100 mg trab għal soluzzjoni orali Sapropterin dihydrochloride
English: Available disease-associated maternal and/or embryofoetal risk data from the Maternal Phenylketonuria Collaborative Study on a moderate amount of pregnancies and live births (between 300-1,000) in PKU-affected women demonstrated that uncontrolled phenylalanine levels above 600 μmol/l are associated with a very high incidence of neurological, cardiac, facial dysmorphism, and growth anomalies.
Maltese: Dejta dwar riskju għall-omm u/jew dwar riskju embrijufetali assoċjata mal-mard, disponibbli millIstudju Kollaborattiv dwar Phenylketonuria Materna (Maternal Phenylketonuria Collaborative Study) fuq ammont moderat ta' tqaliet u twelid ta' trabi ħajjin (bejn 300 sa 1,000) f'nisa affettwati minn PKU, uriet li livelli mhux ikkontrollati ta' phenylalanine ogħla minn 600 μmol/l huma assoċjati ma' inċidenza għolja ħafna ta' anomaliji newroloġiċi, kardijaċi u tat-tkabbir u dismorfiżmu tal-wiċċ.
English: The powder is filled in unit dose sachets containing 500 mg sapropterin dihydrochloride.
Maltese: It-trab huwa mimli fi qratas ta' unità ta' doża li fihom 500 mg ta' sapropterin dihydrochloride.
English: Diarrhoea, vomiting, abdominal pain, dyspepsia, nausea
Maltese: Dijarea, rimettar, uġigħ ta' żaqq, dispepsja, dardir
English: Kuvan 100 mg powder for oral solution Kuvan 500 mg powder for oral solution Sapropterin dihydrochloride
Maltese: Kuvan 100 mg trab għal soluzzjoni orali Kuvan 500 mg trab għal soluzzjoni orali Sapropterin dihydrochloride
English: No tumorigenic activity was observed in an oral carcinogenicity study in mice at doses of up to 250 mg/kg/day (12.5 to 50 times the human therapeutic dose range).
Maltese: Ma ġietx innutata l-ebda attivita' tumoriġenika fi studju karċinoġenitiku fil-ġrieden b'dozi mill-ħalq sa 250 mg/kg/kuljum (12.5 sa 50 darba aktar mill-medda ta' doża terapewtika għal bniedem).
English: The starting dose of Kuvan in adult and paediatric patients with BH4 deficiency is 2 to 5 mg/kg body weight total daily dose.
Maltese: Id-doża tal-bidu f'adulti u f'pazjenti pedjatriċi li jsofru mid-defiċjenza BH4, hija doża totali ta' minn 2 sa 5 mg/kg piż tal-ġisem darba kuljum.
English: Number of 100 mg sachets (dose 20 mg/kg)
Maltese: Numru ta' qratas 100 mg (Doża ta' 20 mg/kg)
English: In healthy subjects, administration of a single dose of Kuvan at the maximum therapeutic dose of 20 mg/kg had no effect on the pharmacokinetics of a single dose of digoxin (P-gp substrate) administered concomitantly.
Maltese: F'individwi b'saħħithom, l-għoti ta' doża unika ta' Kuvan fid-doża terapewtika massima ta' 20 mg/kg ma kellu l-ebda effett fuq il-farmakokinetiċi ta' doża unika ta' digoxin (substrat P-gp) mogħtija flistess ħin.
English: The adjusted mean dietary phenylalanine tolerance in the Kuvan in conjunction with a phenylalanine-restricted diet group was 80.6 mg/kg/day and was statistically significantly greater (p<0.001) than the adjusted mean dietary phenylalanine tolerance in dietary phenylalanine therapy alone group (50.1 mg/kg/day).
Maltese: 001) mill-medja aġġustata tat-tolleranza ta' phenylalanine fid-dieta fil-grupp li kien qed jieħu terapija ta' phenylalanine fid-dieta waħidha (50.1 mg/kg/jum).
English: Each tablet contains 100 mg of sapropterin dihydrochloride (equivalent to 77 mg of sapropterin).
Maltese: Kull pillola fiha 100 mg ta' sapropterin dihydrochloride (ekwivalenti għal 77 mg ta' sapropterin).
English: Kuvan 100 mg powder for oral solution Kuvan 500 mg powder for oral solution
Maltese: Kuvan 100 mg trab għal soluzzjoni orali Kuvan 500 mg trab għal soluzzjoni orali
English: Number of 100 mg tablets (dose 20 mg/kg)
Maltese: Numru ta' pilloli ta' 100 mg (Doża ta' 20 mg/kg)
English: • Transfer the solution by pushing on the plunger slowly until all of the solution in the oral syringe is transferred to a glass or cup for administration (e.g. if your doctor told you to dissolve two Kuvan 100 mg sachets in 40 ml water and administer 30 ml to your child, you would have to use the 20 ml oral syringe two times to draw up 30 ml (e.g. 20 ml + 10 ml) of the solution and transfer it to a glass or cup for administration).
Maltese: • Ittrasferixxi s-soluzzjoni billi timbotta bil-mod fuq il-planġer sakemm is-soluzzjoni kollha fissiringa tal-ħalq tkun ġiet ittrasferita ġo tazza jew kikkra għall-għoti (eż., jekk it-tabib tiegħek qallek biex tħoll żewġ qratas Kuvan 100 mg f'40 ml ta' ilma u tagħti 30 ml lit-tifel/tifla tiegħek, se jkollok tuża s-siringa tal-ħalq ta' 20 ml darbtejn biex tiġbed 30 ml (eż., 20 ml + 10 ml) tassoluzzjoni ta' Kuvan u tittrasferiha ġo tazza jew kikkra għall-għoti).
English: Number of 100 mg sachets (dose 10 mg/kg)
Maltese: Numru ta' qratas 100 mg (Doża ta' 10 mg/kg)
English: The prescribed number of tablets should be placed in a glass or cup with 120 to 240 ml of water and stirred until dissolved.
Maltese: In-numru ta' pilloli preskritti għandhom jitpoġġew f'tazza jew kikkra b'120 sa 240 ml ilma u jiġu mħawda sakemm jinħallu.
English: The measuring devices required for dosing in children up to 20 kg body weight (i.e. cup with graduations at 20, 40, 60, 80 ml; 10 ml and 20 ml oral syringes with graduation at 1 ml divisions) are not included in the Kuvan pack.
Maltese: L-apparat tal-kejl meħtieġ għad-dożaġġ fi tfal b'piż tal-ġisem ta' massimu ta' 20 kg (jiġifieri tazza bi gradwazzjonijiet f'20, 40, 60, 80 ml; siringi tal-ħalq ta' 10 ml u 20 ml bi gradwazzjoni f'diviżjonijiet ta' 1 ml) mhumiex inklużi fil-pakkett ta' Kuvan.
English: Kuvan 100 mg soluble tablets Sapropterin dihydrochloride
Maltese: Kuvan 100 mg pilloli li jinħallu Sapropterin dihydrochloride
English: Kuvan 500 mg powder for oral solution
Maltese: Kuvan 500 mg trab għal soluzzjoni orali
English: Other medicines and Kuvan
Maltese: Kif taħżen Kuvan
English: Drink the dissolved preparation of Kuvan with a meal within 15 to 20 minutes of its preparation.
Maltese: Ixrob ilpreparazzjoni maħlula ta' Kuvan ma' ikla fi żmien 15 sa 20 minuta mill-preparazzjoni tagħha.
English: The powder is filled in unit dose sachets containing 100 mg sapropterin dihydrochloride.
Maltese: It-trab huwa mimli fi qratas ta' unità ta' doża li fihom 100 mg ta' sapropterin dihydrochloride.
English: Each bottle contains a small plastic tube of desiccant (silica gel).
Maltese: Kull flixkun fih tubu tal-plastiku żgħir mimli dessikant (ġel siliċiku).
English: Use a 10 ml oral syringe for administration of volumes ≤10 ml or a 20 ml oral syringe for administration of volumes >10 ml.
Maltese: Uża siringa tal-ħalq ta' 10 ml għallgħoti ta' volumi ta' ≤10 ml jew siringa tal-ħalq ta' 20 ml għall-għoti ta' volumi ta' >10 ml.
English: Number of 100 mg tablets (dose 10 mg/kg)
Maltese: Numru ta' pilloli ta' 100 mg (Doża ta' 10 mg/kg)
English: This medicine contains 1.6 mmol (62.7 mg) potassium per sachet.
Maltese: Dan il-prodott mediċinali fih 1.6 mmol (62.7 mg) ta' potassium f'kull qartas.
English: This medicine contains 0.3 mmol (12.6 mg) potassium per sachet.
Maltese: Dan il-prodott mediċinali fih 0.3 mmol (12.6 mg) ta' potassium f'kull qartas.
English: Since sapropterin dihydrochloride is a synthetic version of the naturally occurring 6R-BH4, it can be reasonably anticipated to undergo the same metabolism, including 6R-BH4 regeneration.
Maltese: Peress li sapropterin dihydrochloride huwa verżjoni sintetika tal-prodott naturali 6R-BH4, wieħed jista' bir-raġun jistenna li jkollu l-istess metaboliżmu, nkluża r-riġenerazzjoni 6R-BH4.
English: Kuvan is indicated for the treatment of hyperphenylalaninaemia (HPA) in adults and paediatric patients of all ages with phenylketonuria (PKU) who have been shown to be responsive to such treatment (see section 4.2).
Maltese: Kuvan huwa indikat għal kura ta' hyperphenylalaninaemia (HPA) f'adulti u pazjenti tfal ta' kull età li jsofru mill-phenylketonuria (PKU), li jkunu ġa` urew rispons għal din il-kura (ara sezzjoni 4.2).
English: Table 2: 5 mg/kg per day dosing table for children weighing up to 20 kg Weight (kg)
Maltese: Tabella 2: Tabella tad-dożaġġ għal doża ta' 5 mg/kg kuljum għal tfal li jiżnu sa 20 kg Piż (kg)
English: If you are pregnant your doctor will tell you how to control phenylalanine levels adequately.
Maltese: Jekk int tqila, it-tabib jgħidlek kif tikkontrolla l-livelli ta' phenylalanine adegwatament.
English: Table 2: 5 mg/kg per day dosing table for children weighing up to 20 kg Weight (kg) Total dose (mg/day)
Maltese: Tabella 2: Tabella tad-dożaġġ għal doża ta' 5 mg/kg kuljum għal tfal li jiżnu sa 20 kg Piż (kg) Doża totali (mg/jum)
English: Do not use this medicine after the expiry date which is stated on the sachet and the carton after “EXP”.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-qartas u l-kartuna wara “EXP”.
English: The rationale for administration of Kuvan in patients with BH4 Deficiency is to replace the deficient levels of BH4, thereby restoring the activity of phenylalanine hydroxylase.
Maltese: Ir-raġunament fl-għoti ta' Kuvan f'pazjenti li jbatu bid-defiċjenza BH4, hu sabiex dan jgħolli l-livelli defiċjenti ta' BH4, b'mod li terġa tiġi rrestawrata l-attivita' ta' phenylalanine hydroxlase.
English: Table 4: 20 mg/kg per day dosing table for children weighing up to 20 kg Weight (kg) Total dose (mg/day)
Maltese: Tabella 4: Tabella tad-dożaġġ għal doża ta' 20 mg/kg kuljum għal tfal li jiżnu sa 20 kg Piż (kg) Doża totali (mg/jum)
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology (CNS, respiratory, cardiovascular, genitourinary), and toxicity to reproduction.
Maltese: Tagħrif mhux kliniku ibbażat fuq studji konvenzjonali ta' sigurtà farmakoloġika (sistema nervuża ċentrali, respiratorja, kardjovaskulari, ġenitourinarja) u effett tossiku fuq is-sistema riproduttiva, ma juri l-ebda periklu speċjali għall-bnedmin.
English: Taking the medicine • Drink the solution within 30 minutes.
Maltese: Kif tieħu l-mediċina • Ixrob is-soluzzjoni fi żmien 30 minuta.
English: Based on the in vitro and in vivo results, co-administration of Kuvan is unlikely to increase systemic exposure to drugs that are substrates for BCRP.
Maltese: Ibbażat fuq ir-riżultati in vitro u in vivo, mhuwiex probabbli li l-għoti flimkien ta' Kuvan iżid l-esponiment sistemiku għall-mediċini li huma substrati għal BCRP.
English: For patients with BH4 deficiency, divide the total daily dose into 2 or 3 administrations, distributed over the day.
Maltese: Għal pazjenti b'defiċjenza ta' BH4, aqsam id-doża totali ta' kuljum f'2 jew 3 dożi, distribwiti tul ilġurnata.
English: Table 3: 10 mg/kg per day dosing table for children weighing up to 20 kg Weight (kg) Total dose (mg/day)
Maltese: Tabella 3: Tabella tad-dożaġġ għal doża ta' 10 mg/kg kuljum għal tfal li jiżnu sa 20 kg Piż (kg) Doża totali (mg/jum)
English: Table 4: 20 mg/kg per day dosing table for children weighing up to 20 kg Weight (kg)
Maltese: Tabella 4: Tabella tad-dożaġġ għal doża ta' 20 mg/kg kuljum għal tfal li jiżnu sa 20 kg Piż (kg)
English: Table 3: 10 mg/kg per day dosing table for children weighing up to 20 kg Weight (kg)
Maltese: Tabella 3: Tabella tad-dożaġġ għal doża ta' 10 mg/kg kuljum għal tfal li jiżnu sa 20 kg Piż (kg)
English: Kuvan 100 mg soluble tablets
Maltese: Kuvan 100 mg pillola li tinħall
English: The recommended starting dose of Kuvan in patients with BH4 deficiency is 2 to 5 mg for each kg of body weight.
Maltese: Fil-bidu, id-doża ta' Kuvan irrakkomandata f'pazjenti li jsofru bid-defiċjenza BH4 hija minn 2 sa 5 mg/kg piż tal-ġisem.
English: In rats, following intravenous radiolabeled sapropterin administration, radioactivity was found to distribute in foetuses.
Maltese: Fil-firien, wara l-injezzjoni fil-vini ta' sapropterin immarkat bir-radioattivita`, instab li r-radjoattivita' xterdet fil-feti.
English: Biotransformation
Maltese: Immaniġġar
English: The rate and extent of absorption of sapropterin is influenced by food.
Maltese: Ir-rata u l-entita' ta' assorbiment ta' sapropterin hija influwenzata mill-ikel.
English: • Small spoon or clean utensil for stirring
Maltese: Kif tipprepara l-qartas/qratas
English: Table 1: 2 mg/kg per day dosing table for children weighing up to 20 kg Weight (kg) Total dose (mg/day)
Maltese: Tabella 1: Tabella tad-dożaġġ għal doża ta' 2 mg/kg kuljum għal tfal li jiżnu sa 20 kg Piż (kg) Doża totali (mg/jum)
English: Active management of dietary phenylalanine and overall protein intake while taking Kuvan is required to ensure adequate control of blood phenylalanine and tyrosine levels and nutritional balance.
Maltese: L-immaniġjar attiv tal-konsum ta' phenylalanine fid-dieta u kemm tittieħed proteina waqt l-użu ta' Kuvan, huwa neċessarju sabiex jiġi żġurat kontroll adegwat tal-livelli ta' phenylalanine u tyrosine fid-demm, kif ukoll ta' bilanċ ta' nutriment.
English: Patients above 20 kg body weight The contents of the sachet(s) should be placed in 120 to 240 ml of water and stirred until dissolved.
Maltese: Użu f'pazjenti ta' aktar minn 20 kg Poġġi l-pilloli f'tazza jew kikkra (120 sa 240 ml) ilma u ħawwad sakemm jinħallu.
English: Package leaflet: Information for the patient Kuvan 500 mg powder for oral solution
Maltese: Informazzjoni għall-pazjent Kuvan 500 mg trab għal soluzzjoni orali
English: In particular you should tell your doctor if you are using: - levodopa (used to treat Parkinson's disease) - medicines for treatment of cancer (e.g. methotrexate) - medicines for treatment of bacterial infections (e.g. trimethoprim) - medicines that cause dilation of blood vessels, (such as glyceryl trinitrate (GTN), isosorbide dinitrate (ISDN), sodium nitroprusside (SNP), molsidomin, minoxidil).
Maltese: B'mod partikulari għandek tavża lit-tabib tiegħek jekk qed tuża: - levodopa (użat fil-kura tal-Marda ta' Parkinson) - medicini għall-kura tal-kanċer (eż. methotrexate), - mediċini għall-kura ta' infezzjonijet batterjali (eż. trimethoprim) - mediċini li jikkawżaw dilatazzjoni tal-vini/arterji tad-demm (bħal glyceryl trinitrate (GTN),
English: • Open the sachet(s) of Kuvan powder for oral solution by folding and tearing, or cutting at the dotted line in the upper right corner of the sachet.
Maltese: • Iftaħ il-qartas/qratas ta' Kuvan trab għal soluzzjoni orali billi tilwi u tqatta', jew taqta' tul il linja miksura fir-rokna ta' fuq tal-lemin tal-qartas.
English: Each soluble tablet contains 100 mg of sapropterin dihydrochloride (equivalent to 77 mg of sapropterin).
Maltese: Kull pillola li tinħall fiha 100 mg sapropterin dihydrochloride (ekwivalenti għal 77 mg ta' sapropterin).
English: Kuvan 100 mg powder for oral solution
Maltese: Kuvan 100 mg trab għal soluzzjoni orali
English: The most commonly reported adverse reactions are “amino acid level decreased” (hypophenylalaninaemia), vomiting and rhinitis.
Maltese: L-iktar reazzjonijiet avversi komuni rrappurati huma “tnaqqis fil-livell ta' amino acid” (hypophenylalaninemia), rimettar u rinite.
English: In both cases, phenylalanine cannot be effectively transformed into the amino acid tyrosine, leading to increased phenylalanine levels in the blood.
Maltese: Fiż-żewġ każijiet phenylalanine qatt ma' jista' jiġi effettivament trasformat fl-amino aċidu tyrosine, li jwassal għal żieda fil-livelli ta' phenylalanine fid-demm.
English: Discard unused solution within 30 minutes for powder solution.
Maltese: Armi kwalunkwe soluzzjoni mhux użata fi żmien 30 minuta għal soluzzjoni tat-trab.
English: Headache and dizziness have been reported after the administration of sapropterin dihydrochloride above the recommended maximum dose of 20 mg/kg/day.
Maltese: Uġigħ ta' ras u sturdament ġew irrapurtati wara l-għoti ta' sapropterin dihydrochloride f'doża iktar għolja minn dik irrakkomandata ta' 20 mg/kg/kuljum.
English: Kuvan is provided as 100 mg tablets.
Maltese: Kuvan huwa pprovdut f'pilloli ta' 100 mg.
English: Common side effects (may affect up to 1 in 10 people) Sore throat, nasal congestion or stuffy nose, cough, diarrhoea, vomiting, stomach ache, too low levels of phenylalanine in blood tests, indigestion and feeling sick (nausea) (see section 2: “Warnings and precautions”).
Maltese: Ħruq fil-griżmejn, konġestjoni jew mnieħer imblukkat, sogħla, dijarea, rimettar, uġigħ fl-istonku, livelli baxxi ħafna ta' phenylalanine kif jirriżulta mit-testijiet tad-demm, indiġestjoni u tħossok ma tiflaħx (dardir) (ara sezzjoni 2: “Twissijiet u prekawzjonijiet”).
English: Package leaflet: Information for the patient Kuvan 100 mg soluble tablets
Maltese: Informazzjoni għall-pazjent Kuvan 100 mg pilloli li jinħallu
English: Do not swallow the desiccant capsule contained in the bottle.
Maltese: Tiblax il-kapsula tad-dessikant li jkun hemm fil-flixkun.
English: • the number of Kuvan 100 mg sachets needed for one dose
Maltese: • In-numru ta' qratas ta' Kuvan 100 mg meħtieġa għal doża waħda
English: 5 mg/ml
Maltese: 5 mg/mL Trab għal dispersjoni għallinfużjoni
English: Antiviral Activity
Maltese: Attività antivirali
English: Candida infections including oral candidiasis.
Maltese: Infezzjonijiet ikkawżati minn Candida inklużi kandidajasi orali.
English: • The active substance is ganciclovir.
Maltese: • Is-sustanza attiva hi ganciclovir.
English: - Prophylaxis:
Maltese: - Profilassi:
English: Cymevene solutions are alkaline (pH ~11).
Maltese: Soluzzjonijiet ta' Cymevene huma alkalini (pH ~11).
English: • probenecid - used for gout,
Maltese: • probenecid - użat għall-gotta,
English: • mycophenolate mofetil - used after an organ transplant,
Maltese: • mycophenolate mofetil - użat wara trapjant ta' organu,
English: Alanine aminotransferase increased
Maltese: Żieda ta' alanine aminotransferase
English: Tabulated list of adverse reactions Infections and infestations:
Maltese: Lista ta' reazzjonijiet avversi f'tabella Infezzjonijiet u infestazzjonijiet:
English: Sensitive human viruses include human cytomegalovirus (HCMV), herpes-simplex virus-1 and -2 (HSV-1 and HSV-2), human herpes virus -6, -7 and -8 (HHV-6, HHV-7, HHV-8), Epstein-Barr virus (EBV), varicella-zoster virus (VZV), and hepatitis B virus.
Maltese: (HCMV - human cytomegalovirus), virus 1 u -2 ta' herpes simplex (HSV 1 u HSV 2 - herpes simplex virus 1 and -2), virus -6, -7 u -8 tal-erpete uman (HHV 6, HHV 7, HHV 8 - human herpes virus -6, -7 and -8), virus Epstein-Barr (EBV - Epstein-Barr virus), virus tal-variċella zoster (VZV - varicella zoster virus), u virus tal-epatite B.
English: • vincristine, vinblastine, doxorubicin - used for cancer,
Maltese: • vincristine, vinblastine, doxorubicin - użati għall-kanċer,
English: (listed in section 6)
Maltese: (elenkati fis-sezzjoni 6)
English: (72) x (0.011 x serum creatinine [micromol/L])
Maltese: 011 x krejatinina fis-serum [mikromol/L])
English: Other antiretrovirals
Maltese: Antiretrovirali oħra
English: The overall incidence of CMV was 16% (15/92 patients).
Maltese: L-inċidenza globali ta' CMV kienet ta' 16% (15/92 pazjent).
English: Dosage reduction is required (see sections 4.2 and 5.2).
Maltese: Huwa meħtieġ tnaqqis fid-dożaġġ (ara sezzjonijiet 4.2 u 5.2).
English: Mean Cmax was 5.5 ± 6 µg/mL at 4 mg/kg and 7.0 ± 1.6 µg/mL at 6 mg/kg.
Maltese: Cmax medja kienet ta' 5.5 ± 6 µg/mL b'4 mg/kg u 7.0 ± 1.6 µg/mL b'6 mg/kg.
English: For females: 0.85 x male value
Maltese: Għan-nisa: 0.85 x valur għall-irġiel
English: Serum creatinine (µmol/L)
Maltese: Krejatinina fisserum (µmol/L)
English: A total of 38.5% of subjects were spared antiviral medications beyond their initial postoperative prophylaxis.
Maltese: Total ta' 38.5% tal-individwi ma ngħatawx mediċini antivirali wara l-profilassi inizjali tagħhom wara l-operazzjoni.
English: Cymevene contains sodium
Maltese: Cymevene fih sodium
English: Intravenous ganciclovir exhibits linear pharmacokinetics over the range of 1.6−5.0 mg/kg.
Maltese: Ganciclovir fil-vini juri farmakokinetika lineari fil-firxa ta' 1.6−5.0 mg/kg.
English: No studies have been conducted in adults older than 65 years of age.
Maltese: Ma twettaq l-ebda studju f'adulti b'età ta' aktar minn 65 sena.
English: Mutagenicity, teratogenicity, carcinogenicity, fertility, and contraception
Maltese: Mutaġeniċità, teratoġeniċità, karċinoġeniċità, fertilità, u kontraċezzjoni
English: • trimethoprim, trimethoprim/sulfamethoxazole, dapsone - used for bacterial infections,
Maltese: • trimethoprim, trimethoprim/sulfamethoxazole, dapsone - użati għal infezzjonijiet ikkawżati minn batterja,
English: Ganciclovir penetrates the cerebrospinal fluid, where concentrations observed reach 24%−67% of the plasma concentrations.
Maltese: Ganciclovir jippenetra l-fluwidu ċerebrospinali, fejn il-konċentrazzjonijiet osservati jilħqu 24%−67% tal-konċentrazzjonijiet filplażma.
English: treatment of cytomegalovirus (CMV) disease in immunocompromised patients;
Maltese: trattament tal-marda ta' ċitomegalovirus (CMV - cytomegalovirus) f'pazjenti immunokompromessi;
English: Rare (≥ 1/10000, < 1/1000)
Maltese: Rari (≥ 1/10000, < 1/1000)
English: Ganciclovir is a potential carcinogen.
Maltese: Ganciclovir huwa karċinoġen potenzjali.
English: There were 9 deaths during the study, 3 in the ganciclovir group and 6 in the control group.
Maltese: Kien hemm 9 imwiet matul l-istudju, 3 fil-grupp ta' ganciclovir u 6 fil-grupp tal-kontroll.
English: Cymevene contains the active substance ganciclovir.
Maltese: Cymevene fih is-sustanza attiva ganciclovir.