FrancophonIA/ELRC3.0 huggingface dataset:
English: After dilution in infusion solutions (sodium chloride 0.9%, dextrose 5%, Ringer's or lactated Ringer's solution for injection) :
Maltese: 0.9%, dextrose 5%, Ringer jew lactated Ringer):
English: Ganciclovir was effective with a toxicity profile similar to that seen in adults.
Maltese: Ganciclovir kien effettiv bi profil ta' tossiċità simili għal dak osservat fl-adulti.
English: Convulsions have been reported in patients taking imipenem-cilastatin and ganciclovir (see sections 4.4 and 4.5).
Maltese: Konvulżjonijiet kienu irrappurtati f'pazjenti li jieħdu imipenem-cilastatin u ganciclovir (ara sezzjonijiet 4.4 u 4.5).
English: As a consequence, pharmacokinetic interactions with protease inhibitors and non-nucleoside reverse transcriptase inhibitors are not anticipated.
Maltese: Bħala konsegwenza, mhux antiċipati interazzjonijiet farmakokinetiċi ma' inibituri tal-protease u ma' inibituri non-nucleoside ta' reverse transcriptase.
English: 10-24 mL/min 1.25mg/kg/day
Maltese: 10-24 mL/min 1.25 mg/kg/jum
English: Asymptomatic CMV infection was detected by PCR in 34.4% of subjects and was more likely in high-risk than in routine-risk recipients (58.1% vs. 21.8%, p = 0.0001).
Maltese: Infezzjoni mingħajr sintomi ta' CMV kienet osservata permess ta' PCR f'34.4% tal-individwi u kienet aktar probabbli f'riċevituri li kellhom riskju għoli milli f'dawk ta' riskju normali (58.1% vs. 21.8%, p = 0.0001).
English: • flucytosine, amphotericin B - used for fungal infections,
Maltese: • flucytosine, amphotericin B - użati għal infezzjonijiet ikkawżati minn fungu,
English: Plasma protein binding was 1%−2% over ganciclovir concentrations of 0.5 and 51 µg/mL.
Maltese: It-twaħħil mal-proteini tal-plażma kien ta' 1%−2% b'konċentrazzjonijiet ta' ganciclovir ta' 0.5 u 51 µg/mL.
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini (EMA): http://www.ema.europa.eu
English: The virustatic activity of ganciclovir is a result of the inhibition of viral DNA synthesis by: (1) competitive inhibition of incorporation of deoxyguanosine triphosphate into DNA by DNA polymerase, and (2) incorporation of ganciclovir triphosphate into viral DNA, causing termination of, or very limited, viral DNA elongation.
Maltese: L-attività virustatika ta' ganciclovir hija riżultat tal-inibizzjoni tas-sintesi tad-DNA virali permezz ta': (1) inibizzjoni kompetittiva ta' inkorporazzjoni ta' deoxyguanosine triphosphate fid-DNA permezz ta' DNA polymerase, u (2) inkorporazzjoni ta' ganciclovir triphosphate fid-DNA virali, li jikkawżaw terminazzjoni ta', jew titwil limitat ħafna tad-DNA virali.
English: Excipient(s) with known effect: approximately 43 mg (2 mEq) sodium.
Maltese: Eċċipjent(i) b'effett magħruf: bejn wieħed u ieħor 43 mg (2 mEq) ta' sodium.
English: Depression Anxiety
Maltese: Depressjoni Ansjetà
English: The pharmacokinetics of intravenous ganciclovir were investigated in neonates aged 2−49 days following doses of 4 mg/kg (N = 14) and 6 mg/kg (N = 13).
Maltese: Il-farmakokinetika ta' ganciclovir fil-vini kienet investigata fi trabi tat-twelid ta' età minn 2−49 jum wara dożi ta' 4 mg/kg (N = 14) u 6 mg/kg (N = 13).
English: Mean Ganciclovir systemic plasma clearance (mL/min)
Maltese: Tneħħija sistemika medja ta' Ganciclovir mill plażma (mL/min)
English: • your age
Maltese: • l-età tiegħek
English: Exposure as measured by mean AUC0−∞ on Days 1 and 14 were 19.4 ± 7.1 and 24.1 ± 14.6 µg.h/mL, respectively, and the corresponding Cmax values were 7.59 ± 3.21 µg/mL (Day 1) and 8.31 ± 4.9 µg/mL (Day 14).
Maltese: L-esponiment kif imkejjel permezz talAUC0−∞ medja f'Jiem 1 u 14 kien ta' 19.4 ± 7.1 u 24.1 ± 14.6 µg.h/mL rispettivament, u l-valuri korrispondenti ta' Cmax kienu ta' 7.59 ± 3.21 µg/mL (Jum 1) u 8.31 ± 4.9 µg/mL (Jum 14).
English: • infertility in men - see ‘Fertility' section
Maltese: • infertilità fl-irġiel - ara s-sezzjoni ‘Fertilità'
English: • didanosine, stavudine, zidovudine or any other medicines used for HIV.
Maltese: • didanosine, stavudine, zidovudine jew xi mediċini oħra użati għall-HIV.
English: • The other ingredients are sodium hydroxide and hydrochloric acid.
Maltese: • Is-sustanzi l-oħra huma sodium hydroxide u hydrochloric acid.
English: • If you have two infusions a day, this will continue for up to 21 days.
Maltese: • Jekk tieħu żewġ infużjonijiet kuljum, dan se jkompli sa 21 jum.
English: Antiviral treatment consisted of either:
Maltese: Trattament antivirali ikkonsista minn:
English: The steady state volume of distribution has a range of 0.54−0.87 L/kg.
Maltese: Il-volum ta' distribuzzjoni fi stat fiss għandu firxa ta' 0.54−0.87 L/kg.
English: In CMV-infected cells, ganciclovir is initially phosphorylated to ganciclovir monophosphate by the viral protein kinase, UL97.
Maltese: F'ċelluli infettati b'CMV, ganciclovir inizjalment huwa fosforilat għal ganciclovir monophosphate permezz tal-protein kinase virali, UL97.
English: 4.5 Interaction with other medicinal products and other forms of interaction Pharmacokinetic interactions
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Interazzjonijiet farmakokinetiċi
English: Cymevene is indicated in adults and adolescents from 12 years of age for the:
Maltese: Cymevene hu indikat f'adulti u addolexxenti ta' età minn 12 il-sena għal:
English: ANNEX III
Maltese: NUMRU(I)
English: Cymevene contains 43 mg of sodium in each 500mg dose.
Maltese: Cymevene fih 43 mg ta' sodium f'kull doża ta' 500mg.
English: Ganciclovir was mutagenic in mouse lymphoma cells and clastogenic in mammalian cells.
Maltese: Ganciclovir kien mutaġeniku f'ċelluli tal-limfoma tal-ġrieden u klastoġeniku f'ċelluli mammiferi.
English: • feeling agitated or nervous
Maltese: • tħossok aġitat jew nervuż
English: Sodium chloride, dextrose 5%, Ringer's or lactated Ringer's solutions are determined chemically or physically compatible with Cymevene.
Maltese: Soluzzjonijiet ta' sodium chloride, dextrose 5%, Ringer jew lactated Ringer huma meqjusa kimikament jew fiżikament kompatibbli ma' Cymevene.
English: Prevention of CMV disease in adults and adolescents from 12 years of age with normal renal function using prophylaxis or pre-emptive therapy
Maltese: Prevenzjoni tal-marda ta' CMV f'adulti u addolexxenti ta' età minn 12-il sena b'funzjoni tal-kliewi normali bl-użu ta' terapija ta' profilassi jew terapija preventiva
English: Paraesthesia
Maltese: Parastesija
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Maltese: Sussegwentement l-informazzjoni tal-prodott tista' tiġi aġġornata mill-awtoritajiet kompetenti tal-Istati Membri, flimkien mal-Istat Membru ta' Referenza, kif xieraq, skont il-proċeduri elenkati f'Kapitlu 4 ta' Titolu III tad-Direttiva 2001/83/KE.
English: Agitation Psychotic disorder
Maltese: Disturb psikotiku
English: Pharmacotherapeutic group: Antivirals for systemic use, direct acting antivirals, nucleosides and nucleotides excluding reverse transcriptase inhibitors, ATC code: J05AB06.
Maltese: Antivirali għall-użu sistemiku, antivirali li jaġixxu b'mod dirett, nukleosidi u nukleotidi minbarra inibituri ta' reverse transcriptase, Kodiċi ATC:
English: Common (≥ 1/100, <1/10):
Maltese: Komuni (≥ 1/100, < 1/10):
English: This has been shown to occur in HSV- and HCMV-infected cells, with half-lives of 18 and 6−24 hours, respectively, after removal of extracellular ganciclovir.
Maltese: Dan intwera li jseħħ f'ċelluli infettati b'HSV- u HCMV-, b'half-lives ta' 18 u 6−24 siegħa, rispettivament, wara t-tneħħija ta' ganciclovir ekstraċellulari.
English: - Maintenance treatment: For immunocompromised patients at risk of relapse maintenance therapy may be given.
Maltese: Għall-pazjenti immunokompromessi f'riskju li jirkadew tista' tingħata terapija ta' manteniment.
English: After dilution:
Maltese: Disturbi vaskulari:
English: Half-lives in subjects without renal impairment ranged from 2.73 ± 1.29 (N = 6) to 3.98 ± 1.78 hours (N = 8).
Maltese: Il-half lives f'individwi mingħajr indeboliment tal-kliewi kienu jvarjaw minn 2.73 ± 1.29 (N = 6) sa 3.98 ± 1.78 sigħat (N = 8).
English: - Intravenous ganciclovir 5 mg/kg daily for 6 weeks followed by oral valganciclovir 17 mg/kg twice daily for 6 weeks then daily until 1 year of age, or - Oral valganciclovir 17 mg/kg twice daily for 12 weeks then daily for 9 months.
Maltese: - Ganciclovir fil-vini 5 mg/kg kuljum għal 6 ġimgħat segwit minn valganciclovir orali 17 mg/kg darbtejn kuljum għal 6 ġimgħat imbagħad kuljum sa età ta' sena, jew - Valganciclovir orali 17 mg/kg darbtejn kuljum għal 12-il ġimgħa imbagħad kuljum għal 9 xhur
English: • blood poisoning (sepsis)
Maltese: • avvelenament tad-demm (sepsis)
English: 0.625 mg/kg/day
Maltese: 0.625 mg/kg/jum
English: At intravenous doses of 5 and 10 mg/kg/day, an increase in the AUC of didanosine ranging from 38% to 67% has been observed.
Maltese: B'dożi fil-vini ta' 5 u 10 mg/kg/jum, kienet osservata żieda fl-AUC ta' didanosine li tvarja minn 38% sa 67%.
English: • kidney or liver problems
Maltese: • problemi biex tibla
English: Mean values for the steady state volume of distribution (0.7 L/kg) and systemic clearance (3.15 ± 0.47 mL/min/kg at 4 mg/kg and 3.55 ± 0.35 mL/min/kg at 6 mg/kg) were comparable to those observed in adults with normal renal function.
Maltese: Valuri medji għall-volum ta' distribuzzjoni fi stat fiss (0.7 L/kg) u ttneħħija sistemika (3.15 ± 0.47 mL/min/kg b'4 mg/kg u 3.55 ± 0.35 mL/min/kg b'6 mg/kg) kienu komparabbli ma' dawk osservati f'adulti b'funzjoni tal-kliewi normali.
English: <10 mL/min 1.25 mg/kg 3x/wk after haemodialysis
Maltese: <10 mL/min 1.25 mg/kg 3x/wk wara l-emodijalisi
English: Urinary tract infection
Maltese: Newtropenija Anemija
English: In patients with mild, moderate, and severe renal impairment, mean systemic clearances of 2.1, 1 and 0.3 mL/min/kg were observed.
Maltese: F'pazjenti b'indeboliment ħafif, moderat, u sever tal-kliewi, kienu osservati tneħħijiet sistemiċi medji ta' 2.1, 1 u 0.3 mL/min/kg.
English: Hallucinations*
Maltese: Alluċinazzjonijiet*
English: Ganciclovir causes impaired fertility and teratogenicity in animals.
Maltese: Fl-annimali Ganciclovir ikkawża indeboliment fil-fertilità u teratoġeniċità.
English: Patients with impaired renal function are at increased risk of toxicity (especially haematological toxicity).
Maltese: Pazjenti b'indeboliment fil-funzjoni tal-kliewi għandhom riskju akbar ta' tossiċità (speċjalment tossiċità ematoloġika).
English: Viral resistance to ganciclovir can arise by selection of mutations in the viral kinase gene (UL97) responsible for ganciclovir monophosphorylation and/or the viral polymerase gene (UL54).
Maltese: Reżistenza virali għal ganciclovir tista' sseħħ permezz ta' għażla ta' mutazzjonijiet fil-ġene ta' kinase virali (UL97) responsabbli għall-monofosforilazzjoni ta' ganciclovir u/jew fil-ġene ta' polymerase virali (UL54).
English: Hepatic function abnormal Blood alkaline phosphatase increased Aspartate aminotransferase increased
Maltese: Żieda ta' aspartate aminotransferase
English: Ganciclovir is a synthetic analogue of 2'-deoxyguanosine, which inhibits replication of herpes viruses both in vitro and in vivo.
Maltese: Ganciclovir huwa analogu sintetiku ta' 2'-deoxyguanosine, li jimpedixxi r-replikazzjoni ta' virusis tal erpete kemm in vitro kif ukoll in vivo.
English: This medicinal product contains 2 mmol (43mg) sodium per 500 mg dose.
Maltese: Eċċipjenti Dan il-prodott mediċinali fih 2 mmol (43 mg) ta' sodium f'kull doża ta' 500 mg.
English: The corresponding values of mean systemic clearance, mean renal clearance, and mean elimination half-life were 4.66 ± 1.72 mL/min/kg, 3.49 ± 2.40 mL/min/kg, and 2.49 ± 0.57 h, respectively.
Maltese: Il-valuri korrispondenti tat-tneħħija sistemika medja, tneħħija medja mill-kliewi, u half-life medja tal-eliminazzjoni kienu ta' 4.66 ± 1.72 mL/min/kg, 3.49 ± 2.40 mL/min/kg, u 2.49 ± 0.57 h, rispettivament.
English: The fraction of ganciclovir removed during a single dialysis session varied from 50% to 63%.
Maltese: Il-porzjon ta' ganciclovir imneħħi waqt sessjoni waħda ta' dijalisi varja minn 50% sa 63%.
English: - Gastrointestinal toxicity: abdominal pain, diarrhoea, vomiting - Neurotoxicity: generalised tremor, convulsion
Maltese: - Tossiċità gastrointestinali: uġigħ addominali, dijarea, rimettar - Newrotossiċità: rogħda ġeneralizzata, aċċessjoni
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains ganciclovir sodium equivalent to 500 mg ganciclovir
Maltese: Kull kunjett fih ganciclovir sodium ekwivalenti għal 500 mg ganciclovir
English: Children treated before 2004 then received oral ganciclovir 30 mg/kg/dose up to 1 g/dose three times daily (n = 41), while children treated after 2004 received valganciclovir up to 900 mg once daily (n = 51).
Maltese: Tfal ittrattati qabel 2004 imbagħad irċevew ganciclovir orali 30 mg/kg/doża sa 1 g/doża tliet darbiet kuljum (n = 41), filwaqt li tfal ittrattati wara 2004 irċevew valganciclovir sa 900 mg darba kuljum (n = 51).
English: 0.625 mg/kg 3x/wk after haemodialysis
Maltese: 0.625 mg/kg 3x/wk wara l-emodijalisi
English: The in vitro antiviral activity, measured as IC50 of ganciclovir against CMV, is in the range of 0.08 µM (0.02 µg/ml) to 14 µM (3.57 µg/ml).
Maltese: L-attività antivirali in vitro, imkejla bħala IC50 ta' ganciclovir kontra CMV, hija fil-firxa ta' 0.08 µM
English: 5.0 mg/kg/day
Maltese: 5.0 mg/kg/jum
English: Sodium hydroxide (for pH-adjustment) Hydrochloric acid (for pH-adjustment)
Maltese: FARMAĊEWTIKU 6.1 Lista ta' eċċipjenti Sodium hydroxide (għall-aġġustament tal-pH) Hydrochloric acid (għall-aġġustament tal-pH)
English: Creatinine clearance renal decreased Renal impairment
Maltese: Tneħħija tal-krejatinina mill-kliewi mnaqqsa Indeboliment tal-kliewi
English: Also do this for at least 90 days after Cymevene has been stopped.
Maltese: Agħmel dan ukoll għal mill inqas 90 jum wara li jitwaqqaf Cymevene.
English: Additional information on special populations
Maltese: Mhux disponibbli informazzjoni speċifika
English: During intermittent haemodialysis, estimates for the clearance of ganciclovir ranged from 42−92 mL/min, resulting in intra-dialytic half-lives of 3.3−4.5 hours.
Maltese: Waqt emodijalisi intermittenti, estimi tat-tneħħija ta' ganciclovir varjaw minn 42−92 mL/min, li jagħtu half-lives waqt id-dijalisi ta 3.3−4.5 sigħat.
English: Preparation of final diluted solution for infusion
Maltese: Preparazzjoni ta' soluzzjoni għall-infużjoni dilwita finali
English: Cytochrome P450 isoenzymes play no role in ganciclovir pharmacokinetics.
Maltese: Isoenzimi ċitokromju P450 m'għandhom l-ebda rwol fil-farmakokinetika ta' ganciclovir.
English: The pharmacokinetic properties of ganciclovir have been evaluated in HIV- and CMV-seropositive patients, patients with AIDS and CMV retinitis, and in solid organ transplant patients.
Maltese: Il-kwalitajiet farmakokinetiċi ta' ganciclovir kienu evalwati f'pazjenti seropożittivi għal HIV u CMV, pazjenti bl-AIDS u b'retinite kkawżata minn CMV, u f'pazjenti li kellhom trapjant ta' organi solidi.
English: Infusion concentrations greater than 10mg/mL are not recommended.
Maltese: Mhumiex rakkomandati konċentrazzjonijiet għall-infużjoni akbar minn 10mg/mL.
English: • eczema, skin problems, itching
Maltese: • ekżema, problemi fil-ġilda, ħakk
English: [See Annex I - To be completed nationally] ganciclovir
Maltese: [Ara Anness I - Biex timtela mill-pajjiż partikolari] Ganciclovir
English: Cymevene will be given to you by a doctor or nurse.
Maltese: Cymevene se jingħata lilek minn tabib jew infermier.
English: A retrospective study investigated the effect of antiviral treatment on late-onset hearing loss in infants with congenital CMV infection (4-34 months of age, mean age 10.3±7.8 months, median age 8 months).
Maltese: Studju retrospettiv investiga l-effett ta' trattament antivirali fuq telf ta' smigħ b'bidu ttardjat fi trabi b'infezzjoni konġenitali ta' CMV (età ta' 4-34 xahar, età medja ta' 10.
English: Treatment of CMV disease in adults and adolescents from 12 years of age with normal renal function
Maltese: Trattament tal-marda ta' CMV f'adulti u addolexxenti ta' età minn 12-il sena b'funzjoni tal-kliewi normali
English: 1.25 mg/kg/day
Maltese: 1.25 mg/kg/jum
English: Pharmacokinetics of intravenous ganciclovir were also studied in infants and children with normal renal function and aged 9 months−12 years.
Maltese: Il-farmakokinetika ta' ganciclovir fil-vini kienet studjata wkoll fi trabi u tfal b'funzjoni tal-kliewi normali u età ta' 9 xhur−12-il sena.
English: In a prospective study, 36 severely immunocompromised paediatric patients (6 months - 16 years of age) with HIV and CMV infection received intravenous ganciclovir at a dose of 5 mg/kg per day for 2 days followed by oral ganciclovir for a median of 32 weeks.
Maltese: Fi studju prospettiv, 36 pazjent pedjatriku immunokompromessi b'mod sever (età ta' 6 xhur - 16-il sena) b'infezzjoni ta' HIV u CMV irċevew ganciclovir fil-vini b'doża ta' 5 mg/kg kuljum għal jumejn segwit minn ganciclovir orali għal medjan ta' 32 ġimgħa.
English: For storage conditions of the diluted solution for infusion, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna tas-soluzzjoni għall-infużjoni dilwita, ara sezzjoni 6.3.
English: • pentamidine - used for parasite or lung infections,
Maltese: • pentamidine - użat għal infezzjonijiet ikkawżati minn parasiti jew infezzjonijiet fil-pulmun,
English: Information on the safety and efficacy of ganciclovir in children under 12 years of age, including neonates, is limited (see sections 4.4, 4.8 and 5.1).
Maltese: Informazzjoni dwar is-sigurtà u l-effikaċja ta' ganciclovir fi tfal ta' età inqas minn 12-il sena, inklużi trabi tat-twelid, hija limitata (ara sezzjonijiet 4.4, 4.8 u 5.1).
English: In a retrospective analysis, the safety and efficacy of ganciclovir was compared to valganciclovir in 92 paediatric kidney and/or liver transplant patients (7 months -18 years of age, median age 9 years).
Maltese: F'analiżi retrospettiva, is-sigurtà u l-effikaċja ta' ganciclovir tqabblu ma' valganciclovir fi 92 pazjent pedjatrika bi trapjant tal-kliewi u/jew tal-fwied (età ta' 7 xhur - 18-il sena, età medjana ta' 9 snin).
English: Twenty-one of 25 ganciclovir recipients had improved hearing or maintained normal hearing from baseline to 6 months compared with 10/17 control patients (84% and 59%, respectively p = 0.06).
Maltese: Wieħed u għoxrin minn 25 riċevitur ta' ganciclovir kellhom titjib fis-smigħ jew żammew smigħ normali mil-linja bażi sa 6 xhur meta mqabbel ma' 10/17-il pazjent tal-kontroll (84% u 59%, rispettivament p = 0.06).
English: Children and adolescents There is limited information on how safe or effective Cymevene is in children under 12 years.
Maltese: Hemm informazzjoni limitata dwar kemm Cymevene hu sikur jew effettiv fi tfal taħt 12-il sena.
English: Do not administer by intramuscular or subcutaneous injection because this may result in severe tissue irritation due to the high pH (~11) of ganciclovir solutions (see section 4.8).
Maltese: Tagħtix permezz ta' injezzjoni ġol-muskoli jew taħt il-ġilda għax dan jista' jwassal għal irritazzjoni severa fit-tessut minħabba l-pH għoli (~ 11) ta' soluzzjonijiet ta' ganciclovir (ara sezzjoni 4.8).
English: Each glass vial contains 500 mg ganciclovir as ganciclovir sodium.
Maltese: Kull kunjett tal-ħġieġ fih 500 mg ganciclovir bħala ganciclovir sodium.
English: Visual impairment Conjunctivitis
Maltese: Indeboliment fil-vista
English: Retinal detachment
Maltese: Reazzjoni anafilattika
English: Male infertility
Maltese: Infertilità fl-irġiel
English: After reconstitution with 10 mL of water for injections, each mL provides 50 mg of ganciclovir.
Maltese: Wara r-rikostituzzjoni b'10 mL ta' ilma għall-injezzjonijiet, kull mL jipprovdi 50 mg ta' ganciclovir.
English: • thrush and oral thrush
Maltese: • traxx u traxx orali
English: Following reconstitution of the powder, 1ml solution contains 50 mg ganciclovir.
Maltese: Wara r-rikostituzzjoni tat-trab, 1ml ta' soluzzjoni fih 50 mg ta' ganciclovir.
English: 25-49 mL/min 2.5 mg/kg/day
Maltese: 2.5 mg/kg/jum25-49 mL/min 2.5 mg/kg/jum
English: There were no deaths secondary to CMV.
Maltese: Ma kien hemm l-ebda mwiet sekondarji għal CMV.
English: Mycophenolate mofetil, stavudine, trimethoprim and zidovudine No significant pharmacokinetic interactions were observed when ganciclovir was administered in combination with either: mycophenolate mofetil, stavudine, trimethoprim or zidovudine.
Maltese: Ma kienu osservati l-ebda interazzjonijiet farmakokinetiċi sinifikanti meta ganciclovir ingħata flimkien ma' wieħed minn dawn: mycophenolate mofetil, stavudine, trimethoprim jew zidovudine.
English: Back pain Myalgia Arthralgia Muscle spasms
Maltese: Uġigħ fid-dahar Uġigħ fil-muskoli Artralġja
English: The infusion should be given into a vein with adequate blood flow, preferably via a plastic cannula.
Maltese: L-infużjoni għandha tingħata ġo vina bi fluss ta' demm adegwat, preferibbilment permezz ta' kannula tal-plastik.
English: Currently available paediatric data are described in sections 5.1 and 5.2, but no recommendation on a posology can be made.
Maltese: Dejta pedjatrika disponibbli bħalissa hi deskritta fis-sezzjonijiet 5.1 u 5.2 imma l-ebda rakkomandazzjoni dwar il-pożoloġija ma tista'
English: Clinical studies have been limited to evaluation of efficacy in patients with CMV infection.
Maltese: Studji kliniċi ġew limitati għall-evalwazzjoni tal-effikaċja f'pazjenti b'infezzjoni ta' CMV.
English: • you are allergic to aciclovir, valaciclovir, penciclovir or famciclovir - these are other medicines used for viral infections
Maltese: • inti allerġiku għal aciclovir, valaciclovir, penciclovir jew famciclovir - dawn huma mediċini oħra użati għal infezzjonijiet ikkawżati minn virusis
English: By one year after baseline, 5/24 ganciclovir recipients and 13/19 control patients had worsening hearing (p < 0.01).
Maltese: Sa sena wara l-linja bażi, 5/24 riċevitur ta' ganciclovir u 13/19il pazjent tal-kontroll kellhom aggravar fis-smigħ (p < 0.01).
English: For patients with severe leucopenia, neutropenia, anaemia and/or thrombocytopenia it is recommended to consider the use of treatment with haematopoietic growth factors and/or the interruption of ganciclovir therapy (see sections 4.2 and 4.8).
Maltese: Għal pazjenti b'lewkopenija, newtropenija, anemija u/jew tromboċitopenija severi huwa rakkomandat li jiġi kkunsidrat l-użu ta' trattament b'fatturi tat-tkabbir ematopoetiċi u/jew l-interruzzjoni ta' terapija ta' ganciclovir (ara sezzjonijiet 4.2 u 4.8).
English: Neutropenia usually occurs during the first or second week of induction therapy and following administration of a cumulative dose of ≤ 200 mg / kg.
Maltese: Newtropenija normalment isseħħ matul l-ewwel jew it-tieni ġimgħa ta' terapija ta' induzzjoni u wara l-għoti ta' doża kumulattiva ta' ≤ 200 mg/kg.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 2 - 8°C (do not freeze).
Maltese: Stabbiltà kimika u fiżika waqt l-użu ntweriet għal 24 siegħa f'temperatura ta' 2 - 8°C (tagħmlux filfriża).
English: The pharmacokinetic characteristics of ganciclovir were the same after single and multiple (q12h) 5 mg/kg intravenous doses.
Maltese: Il-karatteristiċi farmakokinetiċi ta' ganciclovir kienu l-istess wara doża waħda u dożi multipli (q12h) ta' 5 mg/kg fil-vini.
English: See Serious side effects at the top of section 4 for more information.
Maltese: Ara Effetti sekondarji serji fin-naħa ta' fuq tas-sezzjoni 4 għal aktar informazzjoni.
English: Patients treated with ganciclovir and didanosine, medicines known to be myelosuppressive or affecting renal function, should be closely monitored for signs of added toxicity (see section 4.5).
Maltese: Pazjenti ttrattati b'ganciclovir u didanosine, mediċini magħrufa li huma majelosoppressivi jew li jaffettwaw il-funzjoni tal-kliewi, għandhom jiġu mmonitorjati mill-qrib għal sinjali ta' tossiċità miżjuda (ara sezzjoni 4.5).